Surgical instruments, guides, and methods of use

JP2024514585A5Active Publication Date: 2025-04-09PARAGON 28 INC
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Patent Information

Application Number
JP2023562310
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2021-10-21
Filing Date
2022-04-08
Publication Date
2025-04-09
Estimated Expiration
2042-04-08

AI Technical Summary

Technical Problem

Current surgical instruments and guides do not fully address patient needs and fail to consider joint anatomy, leading to suboptimal surgical outcomes.

Method used

A surgical clamp with a unique design featuring a first and second arm, each with distinct engagement elements, allowing for adjustable contact with metatarsals to manipulate and stabilize bones during arthrodesis procedures, including a mechanism to adjust the distance between engagement elements and apply forces to correct the intramedullary angle and rotation of the first metatarsal.

Benefits of technology

The clamp effectively reduces the intramedullary angle and corrects rotational deformities of the first metatarsal, enhancing the precision and efficacy of arthrodesis procedures by ensuring better anatomical alignment and stability.

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Abstract

The present invention relates to a clamp comprising an actuation portion and an engagement portion coupled to the actuation portion by a coupling portion, the engagement portion including a first arm having a first engagement element disposed at a distal end of the first arm and a second arm having a second engagement element disposed at a distal end of the second arm.
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Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 173,043, filed April 9, 2021, entitled "Surgical Instruments, Guides, and Methods of Use," and U.S. Provisional Application No. 63 / 262,845, filed October 21, 2021, both of which are incorporated by reference in their entireties.

[0002] The present disclosure relates to surgical instruments, guides, and methods of use implemented in surgical procedures. The present disclosure relates to podiatric and orthopedic instruments, guides, and methodologies implemented in various procedures of the foot and / or ankle, such as arthrodesis. More specifically, and without limitation, the present disclosure relates to surgical instruments, guides, and methods of use implemented in combination with instruments (and other components, such as implants, devices, systems, assemblies, etc.) for performing arthrodesis of the Lapidus joint. [Background technology]

[0003] Many currently available surgical instruments and guides, as well as methodologies, do not fully address the needs of patients, and furthermore, many currently available surgical instruments, guides, and methodologies do not take into account the characteristics of the joint anatomy, which may result in less than satisfactory outcomes for the patient. Summary of the Invention [Problem to be solved by the invention]

[0004] The present disclosure is directed to surgical guides implemented in combination with implants, instruments, and methods directed to arthrodesis. [Means for solving the problem]

[0005] A first aspect of the present disclosure is a clamp comprising an actuation portion and an engagement portion coupled to the actuation portion via a coupling portion, the engagement portion comprising a first arm and a second arm, the first arm including a first engagement element disposed at a distal end of the first arm, and the second arm including a second engagement element disposed at a distal end of the second arm.

[0006] According to a first aspect of the present disclosure, the first engagement element and the second engagement element are different.

[0007] According to a first aspect of the present disclosure, the second engagement element is integral with the second arm.

[0008] According to a first aspect of the present disclosure, the second engagement element has a vertically tapered shape.

[0009] According to a first aspect of the present disclosure, the second engagement element includes a flat portion disposed on an inner surface thereof, the flat portion including a textured surface.

[0010] According to a first aspect of the present disclosure, the textured surface is configured to contact at least a portion of the first metatarsal such that the second engagement element maintains contact with the first metatarsal.

[0011] According to a first aspect of the present disclosure, the first arm includes an aperture located at a distal end, the aperture configured to rotatably couple with a first engagement element.

[0012] According to a first aspect of the present disclosure, the first actuator is disposed at an end of the first portion opposite the second portion.

[0013] According to a first aspect of the present disclosure, the first engagement element includes a retainer and an actuator.

[0014] According to a first aspect of the disclosure, the retainer includes a post, at least a portion of which is configured to be received in an aperture in the first arm to facilitate a rotatable and releasable coupling between the first engagement element and the first arm.

[0015] According to a first aspect of the disclosure, the actuator includes a central opening configured to receive at least a portion of the post such that the actuator is positioned above the opening in the first arm and above the retainer.

[0016] According to a first aspect of the present disclosure, the retainer further includes a first retaining element and a second retaining element extending from the post.

[0017] According to a first aspect of the present disclosure, the distance between the first and second retaining elements is adjusted by manipulating an actuator around a screw disposed on a surface of the retaining portion.

[0018] According to a first aspect of the present disclosure, the first retaining element and the second retaining element each include a textured surface configured to interface with the second metatarsal bone.

[0019] According to a first aspect of the present disclosure, the retainer is rotatably coupled to the opening of the first arm to include a 360 degree range of motion.

[0020] According to a first aspect of the present disclosure, the first arm has a different shape than the second arm.

[0021] According to a first aspect of the invention, the first engagement element has a depth different from a depth of the second engagement element.

[0022] A second aspect of the present disclosure is a surgical system, the surgical system including a clamp. The clamp includes an actuation portion and an engagement portion. The engagement portion is coupled to the actuation portion by a coupling portion disposed between the engagement portion and the actuation portion. The engagement portion includes a first arm having a first engagement element disposed at a distal end of the first arm, the first engagement element being integral with the first arm and configured to contact a surface of the first bone. The engagement portion also includes a second arm having a second engagement element disposed at a distal end of the second arm, the second engagement element comprising an actuator rotatably and releasably coupled to the second arm and configured to adjust a distance between the first and second retention elements such that each of the first and second retention elements engages at least a portion of the second bone. The surgical system further includes a fixation device.

[0023] According to a second aspect of the present disclosure, by operating the actuator, the distance between the first engagement element and the second engagement element is increased or decreased.

[0024] According to a second aspect of the disclosure, the second engagement element comprises a retainer including a post and a thread, the post configured to releasably couple with the second arm and the thread configured to releasably couple with the actuator.

[0025] A third aspect of the present disclosure is a surgical method, the method including: aligning a retaining element including a post and a pair of extensions disposed on opposite sides of the post such that a first bone is at least partially disposed between each of the pair of extensions, releasably coupling a surgical clamp to the post of the retaining element such that the post is received in a portion of a first arm of the surgical clamp, and manipulating an actuator such that each of the pair of extensions contacts and releasably couples with at least a portion of the first bone. The method also includes manipulating the surgical clamp such that an engagement element disposed on a second arm of the surgical clamp contacts a surface of the second bone, coupling a first stabilization wire to the second bone, reducing an intramedullary angle between the first and second bones, and derotating the second bone by manipulating the first stabilization wire. The method also includes inserting a second stabilization wire through the through hole in the second arm and into the second bone, making one or more incisions in the one or more bones, and applying a fixation device across the first and third bones.

[0026] A fourth aspect of the present disclosure is a surgical system including a clamp. The clamp includes a first portion having a first actuator configured to interface with a first metatarsal of a patient, the first portion having a range of movement of the actuator defined by an aperture, and a second portion having an extension with a retention mechanism configured to interface with a second metatarsal of the patient. The second portion is releasably coupled to the first portion, and the first and second portions are translatable relative to one another via the second actuator. The system also includes a stabilization wire configured to be received by at least one of the first and second portions.

[0027] According to a fourth aspect of the present disclosure, a first actuator includes a first bore disposed about a longitudinal axis of the actuator.

[0028] According to a fourth aspect of the present disclosure, the first bore is configured to receive one of a plurality of stabilization wires therein and through the bore such that the stabilization wire can releasably couple the first actuator to the first metatarsal.

[0029] According to a fourth aspect of the present disclosure, manipulation of a first actuator within the aperture applies a rotational force to the first metatarsal via the stabilization wire to manipulate the first metatarsal from a first position to a second position.

[0030] According to a fourth aspect of the present disclosure, operation of a first actuator within the aperture moves the stabilization wire from a first position forming a first angle with the transverse plane to a second position forming a second angle with the transverse plane, where the first angle is different from the second angle.

[0031] According to a fourth aspect of the present disclosure, the first angle is greater than the second angle.

[0032] According to a fourth aspect of the present disclosure, the retention feature is disposed at a distal end of the extension and includes a pair of curved protrusions defining a recess therebetween.

[0033] According to a fourth aspect of the present disclosure, the protrusion is curved toward the first portion of the clamp.

[0034] According to a fourth aspect of the present disclosure, the second actuator is disposed at an end of the second portion opposite the first portion.

[0035] According to a fourth aspect of the present disclosure, the second portion includes a bore extending through the second portion along a longitudinal axis thereof.

[0036] According to a fourth aspect of the present disclosure, the second actuator includes a protrusion having a first coupling mechanism configured to be received by and extend through the bore, the protrusion configured to releasably couple with the second portion via the bore.

[0037] According to a fourth aspect of the present disclosure, the first portion includes a recess including a second coupling feature, the recess configured to receive and releasably couple a portion of a protrusion of a second actuator.

[0038] According to a fourth aspect of the present disclosure, the recess of the first part and the bore of the second part share a common axis of the protrusion when both are releasably coupled to the protrusion of the second actuator.

[0039] According to a fourth aspect of the present disclosure, operation of the second actuator causes the first portion to be translated relative to the second portion about the shared axis.

[0040] According to a fourth aspect of the present disclosure, the first actuator and the second actuator each include a texture applied to one or more outer surfaces thereof.

[0041] According to a fourth aspect of the present disclosure, the second portion includes one or more protrusions, each protrusion including an aperture configured to receive one of the stabilization wires.

[0042] A fifth aspect of the present disclosure is a surgical clamp comprising a first portion having a substantially curved shape. The first portion includes a recess located at a proximal end of the first portion, an elongated opening located at a distal end of the first portion, and a first actuator at least partially disposed within the elongated opening such that the elongated opening defines a range of movement thereof. The first actuator includes a bore extending therethrough along a longitudinal axis thereof and configured to receive a stabilizing wire. The surgical clamp also includes a second portion. The second portion includes an extension including a pair of protrusions at a distal end thereof, a bore extending along a longitudinal axis of the second portion, and a second actuator including a coupling mechanism configured to be received through the bore and releasably coupled to the bore. The coupling mechanism is configured to be received in the recess and releasably coupled such that operation of the second actuator causes the first portion and the second portion to translate about the longitudinal axis of the second portion.

[0043] According to a fifth aspect of the present disclosure, the first portion includes at least one bore configured to receive a stabilization wire.

[0044] According to a fifth aspect of the present disclosure, the second portion includes at least an opening configured to receive a stabilization wire.

[0045] A sixth aspect of the present disclosure is a method of performing a Lapidus joint procedure. The method includes coupling a first portion of a device to a second metatarsal with a first stabilization wire and a second stabilization wire, and coupling a second portion of the device to the first metatarsal with a third stabilization wire received by a first actuator of the second portion. The method also includes manipulating a second actuator disposed on the first portion of the device to reduce a distance between the first metatarsal and the second metatarsal, and manipulating the first actuator to rotate the first metatarsal. The method further includes coupling a surgical guide adjacent the Lapidus joint to a fourth stabilization wire, preparing a distal portion of the medial cuneiform and a proximal portion of the first metatarsal for fixation such that the distal portion of the medial cuneiform has a surface substantially parallel to a proximal surface of the first metatarsal, and applying a fixation device across the Lapidus joint.

[0046] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the present invention and, together with the detailed description herein, serve to explain the principles of the present invention. It is emphasized that, in accordance with standard industry practice, various features may or may not be drawn to scale. In fact, dimensions of various features may be arbitrarily increased or decreased for clarity of discussion. The drawings are only for the purpose of illustrating inventive embodiments of the present disclosure and are not to be construed as limiting the present invention. [Brief description of the drawings]

[0047] [Figure 1] FIG. 1 is a front perspective view of an exemplary system implemented in performing a surgical procedure in accordance with the present disclosure; [Diagram 2] FIG. 2 is a front view of the system of FIG. 1 according to the present disclosure; [Diagram 3] FIG. 2 is a rear perspective view of the system of FIG. 1 according to the present disclosure; [Figure 4] FIG. 2 is a top view of the system of FIG. 1 shown adjacent a portion of an anatomical structure in accordance with the present disclosure; [Diagram 5]FIG. 2 is a front perspective view of the system of FIG. 1 shown adjacent a portion of an anatomical structure in accordance with the present disclosure; [Figure 6] FIG. 2 is a front perspective view of the system of FIG. 1 shown adjacent a portion of an anatomical structure in accordance with the present disclosure; [Figure 7] FIG. 1 is a front right perspective view of an exemplary system implemented when performing a surgical procedure in accordance with the present disclosure; [Figure 8] FIG. 8 is a top view of the system of FIG. 7 according to the present disclosure. [Figure 9] FIG. 8 is a front view of the system of FIG. 7 according to the present disclosure. [Figure 10] FIG. 8 is a rear perspective view of the system of FIG. 7 according to the present disclosure. [Figure 11] FIG. 1 is a front perspective view of an exemplary retention mechanism implemented when performing a surgical procedure in accordance with the present disclosure; [Figure 12] FIG. 12 is a front view of the mechanism of FIG. 11 according to the present disclosure; [Figure 13] FIG. 12 is a bottom perspective view of the mechanism of FIG. 11 according to the present disclosure; [Figure 14] FIG. 12 is a top perspective view of the mechanism of FIG. 11 according to the present disclosure; [Figure 15] FIG. 12 is a front view of a portion of the mechanism of FIG. 11 according to the present disclosure; [Figure 16] FIG. 12 is a top perspective view of another portion of the mechanism of FIG. 11 according to the present disclosure; [Figure 17] FIG. 1 is a front view of an exemplary mechanism implemented when performing a surgical procedure in accordance with the present disclosure; [Figure 18] FIG. 18 is a front perspective view of the mechanism of FIG. 17 according to the present disclosure; [Figure 19] FIG. 18 is a bottom perspective view of the mechanism of FIG. 17 according to the present disclosure; [Figure 20] FIG. 18 is a top perspective view of the mechanism of FIG. 17 according to the present disclosure; [Figure 21] FIG. 18 is a front view of a portion of the mechanism of FIG. 17 according to the present disclosure. [Figure 22] FIG. 18 is a top perspective view of a portion of the mechanism of FIG. 17 in accordance with the present disclosure; [Diagram 23] FIG. 1 is a front perspective view of an exemplary mechanism implemented when performing a surgical procedure in accordance with the present disclosure; [Figure 24] FIG. 24 is a bottom perspective view of the mechanism of FIG. 23 according to the present disclosure; [Diagram 25] FIG. 24 is a top view of the mechanism of FIG. 23 according to the present disclosure. [Figure 26] FIG. 24 is a front view of a portion of the mechanism of FIG. 23 according to the present disclosure; [Figure 27] FIG. 1 is a top view of an exemplary system implemented when performing a surgical procedure in accordance with the present disclosure; [Figure 28] FIG. 28 is a top perspective view of the system of FIG. 27 in accordance with the present disclosure. [Figure 29] FIG. 28 is a front view of the system of FIG. 27 according to the present disclosure. [Diagram 30] FIG. 28 is another front view of the system of FIG. 27 according to the present disclosure. [Diagram 31] FIG. 28 is a side perspective view of the system of FIG. 27 according to the present disclosure. [Diagram 32] FIG. 28 is a top view of the system of FIG. 27 according to the present disclosure. [Diagram 33] FIG. 28 is a front view of a retaining element of the system of FIG. 27 in accordance with the present disclosure. [Diagram 34] FIG. 34 is a side view of the retaining element of FIG. [Figure 35A] 1 is a flow chart illustrating method steps performed when performing a surgical procedure in accordance with the present disclosure. [Figure 35B] 35B is a flow chart illustrating subsequent steps of a method of implementation when performing the surgical procedure of FIG. 35A in accordance with the present disclosure. [Diagram 36] FIG. 1 is a side perspective view of a system for positioning an orthopedic implant in accordance with the present disclosure; [Figure 37] FIG. 37 is another side perspective view of the system for positioning the orthopedic implant of FIG. 36 in accordance with the present disclosure; [Figure 38] FIG. 37 is a side cross-sectional view of a system for positioning an orthopedic implant of FIG. 36 in accordance with the present disclosure; [Figure 39] FIG. 1 is a front perspective view of an exemplary system implemented in performing a surgical procedure in accordance with the present disclosure; [Diagram 40] FIG. 40 is a rear perspective view of the system of FIG. 39 in accordance with the present disclosure; [Diagram 41] FIG. 40 is a right side view of the system of FIG. 39 in accordance with the present disclosure. [Diagram 42]FIG. 40 is a left side view of the system of FIG. 39 in accordance with the present disclosure. [Diagram 43] FIG. 40 is a top view of the system of FIG. 39 in accordance with the present disclosure. [Diagram 44] FIG. 40 is a bottom view of the system of FIG. 39 in accordance with the present disclosure. [Diagram 45] FIG. 40 is a rear view of the system of FIG. 39 in accordance with the present disclosure. [Figure 46] FIG. 40 is a front view of the system of FIG. 39 in accordance with the present disclosure. [Figure 47] FIG. 40 is a rear perspective view of the system of FIG. 39 shown with respect to the anatomy of the foot in accordance with the present disclosure; [Figure 48] FIG. 48 is another rear perspective view of the system of FIG. 47 shown with respect to the anatomy of the foot in accordance with the present disclosure; [Figure 49] FIG. 40 is a rear perspective view of the system of FIG. 39 shown with respect to the anatomy of the foot in accordance with the present disclosure; [Figure 50] FIG. 40 is a rear perspective view of the system of FIG. 39 including an exemplary surgical guide shown with respect to the anatomy of the foot in accordance with the present disclosure; [Figure 51] FIG. 51 is another rear perspective view of the system of FIG. 39 including the surgical guide of FIG. 50 shown with respect to the anatomy of the foot in accordance with the present disclosure; [Figure 52] FIG. 40 is a rear perspective view of the system of FIG. 39 including an exemplary surgical guide shown with respect to the anatomy of the foot in accordance with the present disclosure; [Figure 53] FIG. 40 is a high back perspective view of the system of FIG. 39 shown with respect to the anatomy of the foot in accordance with the present disclosure; [Figure 54] FIG. 1 is a perspective view of a stabilization system for facilitating implementation of a fastening system according to the present disclosure; [Figure 55] FIG. 1 is a front perspective view of an exemplary system implemented in performing a surgical procedure in accordance with the present disclosure; [Figure 56] FIG. 56 is a rear perspective view of the system of FIG. 55 in accordance with the present disclosure. [Figure 57] FIG. 56 is a right side view of the system of FIG. 55 in accordance with the present disclosure. [Figure 58] FIG. 56 is a left side view of the system of FIG. 55 in accordance with the present disclosure. [Figure 59] FIG. 56 is a top view of the system of FIG. [Figure 60] FIG. 56 is a bottom view of the system of FIG. [Figure 61] FIG. 56 is a rear view of the system of FIG. [Figure 62] FIG. 56 is a front view of the system of FIG. [Figure 63] FIG. 56 is an exploded view of the system of FIG. [Figure 64] FIG. 1 is a perspective view of an exemplary embodiment of a surgical guide according to the present disclosure; [Figure 65] FIG. 65 is a side view of the surgical guide of FIG. [Figure 66] 1 is a flowchart of a method for performing a Lapidus joint procedure in accordance with the present disclosure; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0048] In this detailed description and in the claims, the terms proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior, and inferior are defined by standard usage to designate a particular part or portion of a bone or implant according to the relative placement or orientation of natural bone. For example, "proximal" refers to the portion of the device or implant closest to the body and "distal" refers to the portion of the device or implant furthest from the body. As terms relating to direction, "anterior" refers to a direction toward the front of the body, "posterior" refers to a direction toward the back of the body, "medial" refers to a direction toward the midline of the torso, "lateral" refers to a direction toward the side of the body or away from the midline of the body, superior means in a direction above, and inferior means in a direction toward under another object or structure. Additionally, with respect to the foot specifically, the term "dorsal" refers to the top of the foot and the term "plantar" refers to the bottom of the foot.

[0049] Similarly, a location or orientation may be used herein with respect to an anatomical structure or surface. For example, implants, devices, instruments, and methods herein described with reference to use on the bones of the foot, ankle, and lower leg may be used to describe the surface, location, direction, or orientation of the implants, devices, instruments, and methods. Furthermore, the implants, devices, instruments, and methods disclosed herein, as well as their aspects, components, features, etc., are described with respect to one side of the body for the sake of brevity. However, since the human body is relatively symmetrical or mirrored about a line of symmetry (midline), it is expressly understood that the implants, devices, instruments, and methods described and / or illustrated herein, as well as their aspects, components, features, etc., may be changed, altered, modified, reconfigured, or otherwise modified for use or association with another side of the body for the same or similar purposes without departing from the spirit and scope of the present invention. For example, the implants, devices, instruments, and methods described herein with respect to the right foot, as well as their aspects, components, features, etc., may be mirrored to function similarly on the left foot. Additionally, while the implants, devices, instruments, and methods disclosed herein, and their aspects, components, features, etc., are described with respect to the foot for the sake of brevity, it should be understood that these implants, devices, instruments, and methods may also be used with other bones of the body having a similar structure.

[0050] The presently disclosed instruments, implants, systems, assemblies, and related methods for maintaining, correcting, and / or resurfacing joint surfaces may be similar to, and may include at least one feature or aspect of, the implants, systems, assemblies, and related methods disclosed below, for example, in PCT International Application No. PCT / US2018 / 20046, filed February 27, 2018, and entitled "INTRAMEDULLARGE NAIL ALIGNMENT GUIDE, FIXATION GUIDE, DEVICE, SYSTEM, AND METHODS OF USE," PCT International Application No. PCT / US2018 / 64386, filed December 17, 2018, and entitled "ALIGNMENT GUIDE, CUTTING GUIDE, SYSTEM, AND METHODS OF USE AND ASSEMBLY," PCT International Application No. PCT / US2019 / 64387, filed July 10, 2019, and entitled "GUIDES, INSTRUMENTS, SYSTEMS, No. PCT / US2019 / 041146, filed on March 14, 2014, entitled "INTRAMEDULLARGE NAIL FIXATION GUIDE, APPARATUS, AND METHODS OF USE" and / or PCT / US2014 / 27086, filed on November 19, 2014, entitled "Step-Off Bone Plates, Systems, and Methods of Use" and / or U.S. Patent No. 9,980,760, filed on July 26, 2012 ... November 19, 2014, entitled "Step-Off Bone Plates, Systems, and Methods of Use" and / or U.S. Patent No. No. D720,456, filed on October 23, 2014, entitled "RAPIDUS BONE WEDGE" and / or U.S. Patent No. D765,844, filed on October 23, 2014, entitled "Bone Plate" and / or U.S. Patent No. D695,402, filed on December 10, 2013, entitled "RAPIDUS CUT GUIDE" and / or U.S. Patent No. D904,2016, filed on November 22, 2017, entitled "INTRAMEDULLARGE FASTENER" and / or or U.S. Patent No. D865,173, filed July 9, 2018 and entitled "Cut Guide", and / or U.S. Patent No. 29 / 686,941, filed April 9, 2019 and entitled "Cut Guide", and / or U.S. Patent No. D904,609, filed April 9, 2019 and entitled "Cut Guide", and / or U.S. Patent No. D904,2010, filed April 9, 2019 and entitled "Cut Guide", which are incorporated herein by reference in their entireties.Similarly, instruments, implants, systems, assemblies, and related methods for maintaining, correcting, and / or resurfacing articular surfaces according to the present disclosure may include one or more instruments (e.g., one or more insertion and / or implantation instruments) disclosed below, for example, in U.S. Provisional Application No. 63 / 173,043, filed April 9, 2021, entitled "Surgical Instruments, Guides, and Methods of Use," and / or in PCT International Application No. PCT / US2018 / 20046, filed February 27, 2018, entitled "Intramedullary Nail Alignment Guides, Fixation Guides, Devices, Systems, and Methods of Use," and / or in PCT International Application No. PCT / US2018 / 20047, filed December 17, 2018, entitled "Alignment Guides, Cut Guides, Systems, and Methods of Use and Assembly." PCT International Application No. PCT / US2018 / 64368, PCT International Application No. PCT / US2019 / 041146, filed on July 10, 2019, entitled “GUIDES, APPARATUS, SYSTEMS, AND METHODS OF USE”, and / or PCT International Application No. PCT / US2014 / 27086, filed on March 14, 2014, entitled “INTRAMEDULLARGE NAIL FIXATION GUIDES, DEVICES, AND METHODS OF USE”, and / or PCT International Application No. PCT / US2014 / 27086, filed on November 19, 2014, entitled “STEP-OFF BONE PLATES, SYSTEMS, AND METHODS OF USE”, No. 9,980,760, filed on July 26, 2012, entitled "RAPIDUS BONE WEDGE", and / or U.S. Patent No. D720,456, filed on October 23, 2014, entitled "BONE PLATE", and / or U.S. Patent No. D695,402, filed on December 10, 2013, entitled "RAPIDUS CUT GUIDE", and / or U.S. Patent No. D720,456, filed on July 26, 2012, entitled "RAPIDUS BONE WEDGE", and / or U.S. Patent No. D765,844, filed on October 23, 2014, entitled "BONE PLATE", and / or U.S. Patent No. D695,402, filed on December 10, 2013, entitled "RAPIDUS CUT GUIDE", and / or U.S. Patent No. D720,456, filed on July 26, 2012, entitled "BONE PLATE", and / or U.S. Patent No. D720,456, filed on July 26, 2012 ...BONE PLATE", and / or U.S. Patent No. D720,456, filed on July 26, 2012, entitled "BONE PLATE", and / or U.S. Patent No. D720,456, filed on October 23, 2014, entitled "BONE PLATE", and / or U.S. Patent No. D695, Patent No. D904,2016, and / or U.S. Patent No. D865,173, filed on July 9, 2018, entitled "Cut Guide", and / or U.S. Patent No. 29 / 686,941, filed on April 9, 2019, entitled "Cut Guide", and / or U.S. Patent No. D904,609, filed on April 9, 2019, entitled "Cut Guide", and / or U.S. Patent No. D904,2010, filed on April 9, 2019, entitled "Cut Guide".These are incorporated herein by reference in their entireties.

[0051] Procedures addressing deformities such as hallux valgus and the Lapidus joint and surrounding anatomy frequently require positioning / relocation and / or rotation / derotation of the first metatarsal. The joint referred to herein as the "Lapidus" joint is also known and sometimes referred to as the first tarsometatarsal joint. Lapidus joint procedures (e.g., fixation / arthrodesis) typically require manipulation of the first metatarsal by applying one or more forces to the first metatarsal. In some procedures, this manipulation is necessary before incision and / or preparation and subsequent fixation of the Lapidus joint are performed. When determining a deformity of the Lapidus joint, two different criteria are usually analyzed for correction. One of these criteria is the intramedullary angle formed between the longitudinal axes of the first and second metatarsals. In bunion deformities and other conditions of the Lapidus joint, the first metatarsal is often displaced medially from its normal anatomical position, resulting in an increase in the IM angle between the first and second metatarsals from the range of angles considered anatomically correct. Rotation of the first metatarsal is also analyzed, as hallux valgus deformities and other conditions of the Lapidus joint typically involve the first metatarsal being rotated in a substantially clockwise direction (when viewed from anterior to posterior) in the frontal plane. Generally, such treatment of the Lapidus joint requires manipulation of the first metatarsal to a) modify (e.g., reduce) the IM angle between the first and second metatarsals by applying a substantially lateral force to the first metatarsal, and / or b) derotate the first metatarsal that has been rotated from its normal anatomical position by applying a rotational force in a substantially counterclockwise direction when viewing the first metatarsal in an anterior to posterior direction.

[0052] In the drawings, like reference numbers are used throughout the several views to indicate like or similar components. With reference to FIGS. 1-6, an exemplary embodiment of a clamp 100 is shown that may be implemented when performing a procedure on one or more anatomical structures of the foot (e.g., a procedure on the Lapidus joint, e.g., arthrodesis or other similar fixation procedure). In some aspects, the clamp 100 may be manipulated such that one or more components of the clamp contact one or more anatomical structures of the foot. When a force is applied to the clamp by the physician, at least one of the anatomical structures is selectively repositioned by the physician. As shown in FIGS. 1-6, the clamp 100 includes an upper portion 110 (e.g., a handle, etc.) that is disposed substantially opposite the clamp 100 from a lower portion 120 (e.g., an engagement portion, a coupling portion, etc.). A coupling 118 is disposed between the upper portion 110 and the lower portion 120. The illustrated clamp 100 includes a pair of members pivotally coupled by a coupling 118, with each member of the pair including at least a portion of an upper portion 110 and a portion of a lower portion 120. A ratchet 116 can be configured to adjust the clamp from a first position to a second position or to hold the clamp in a desired position (e.g., to maintain some desired correction). In some aspects, the coupling 118 can include a geometry that defines a range of movement of the upper portion 110 and / or lower portion 120 of the clamp 100, such as a ratchet as shown or other coupling mechanism.

[0053] The clamp 100 includes a first arm 122 and a second arm 124 extending from the coupling 118 at a lower portion 120 of the clamp as shown. As shown, the first arm 122 and the second arm 124 are integral with the first handle portion 112 and the second handle portion 114 (the first handle portion 112 is integral with the second arm 124, and the second handle portion 114 is integral with the first arm 122). The first arm 122 is shown to include a bend disposed between the coupling 118 and an interface component 123, the interface component 123 being disposed at the terminus of the first arm 122. As shown, the interface component 123 is disposed substantially perpendicular (e.g., bent plantarly) to the first arm 122 between the coupling 118 and said bend (although some embodiments may have other arrangements). As shown in at least Figures 4-6, the interface component 123 further has a curvature configured to accommodate the curvature of a medial portion of the first metatarsal 202. In some embodiments, the interface component 123 can be configured to interface with a distal portion of the first metatarsal 202. The interface component 123 can also include a textured surface on at least one surface of the interface component 123 (e.g., a surface having a concave curvature to accommodate the first metatarsal 202) to promote prolonged contact with the surface of the first metatarsal 202 by increasing friction with the surface of the first metatarsal 202.

[0054] The second arm 124 is shown to include a retaining element 125 disposed at a terminal end of the second arm 124, which can be releasably coupled to the second arm 124. As shown, the retaining element 125 includes a post 132 (seen at least in FIGS. 11-12 ) configured to be received in an opening of the second arm 124 (moving in a direction from the bottom to the top of the foot). The retaining element 123 is configured, in some embodiments, at its distal portion to facilitate coupling with the second metatarsal 204. The retaining element 123 is configured to be pivotable within the opening of the second arm 124 to facilitate coupling with the second metatarsal 204 despite various lateral geometries of the second metatarsal 204.

[0055] The retention element 125 includes a first element 130 and a second element 140, as further shown in FIGS. 11-16. The first element 130 includes a post 132 at its upper portion (e.g., an upper portion) and a pair of engagement elements 134 disposed at its lower portion (e.g., opposite the post 132). The illustrated post 132 includes a thread 136 disposed on at least a portion thereof. As shown, the thread 136 is disposed on the lower portion of the post 132. The illustrated engagement element 134 is a pair of prongs extending from a lower portion of the post 132 adjacent the lower portion of the thread 136. The engagement element 134 includes a first segment 138 extending perpendicularly from the lower portion of the post 132. The engagement element 134 further includes a second segment 139 extending from the first segment 138 to a terminal end of the engagement element 134. As shown, the second segments 139 are substantially parallel to one another. The inner surfaces of the second segments 139 (eg, the surfaces that face each other) include a texture configured to induce friction upon contact with bone and promote bone retention therebetween.

[0056] As shown, the retention element 125 further includes an actuator 140. The actuator 140 is configured to adjust the distance between the engagement elements 134 to position the engagement elements 134 adjacent to the second metatarsal 204, and ultimately further adjust the distance between the engagement elements 134 to initiate contact (e.g., engagement, releasable coupling, etc.) with the second metatarsal 204. The actuator 140 includes an aperture 142 configured to receive the post 132 therethrough. The aperture 142 further includes threads 143 disposed on an inner surface of the aperture 142 having a geometry complementary to the geometry of the threads 136 to facilitate a threadable and releasable coupling. The actuator 140 also includes a texture 144 disposed on an outer surface thereof to facilitate gripping and manipulation of the actuator 140. The actuator 140 is configured as follows: That is, when the first element 130 is positioned such that the engaging element 134 is positioned adjacent the second metatarsal 204, the actuator can be releasably coupled to the post 132 such that the threads 136 and 143 engage, causing the actuator 140 to move downward along the threads 136 of the post 132. As the actuator 140 begins to contact the engaging element 134, the force applied by the actuator 140 can drive the engaging elements 134 closer together (e.g., the actuator 140 begins to receive at least a portion of the engaging element 134 within the opening 142 of the actuator 140, thereby driving the engaging elements 134 closer together). This reduces the space between the engaging elements 134, causing the medial and lateral surfaces of the second metatarsal 204 to be gripped by the second segment 139 of the retention element 125. The clamp 100 may then be releasably coupled to the post 132 of the retaining element 125 by positioning the clamp such that the opening in the second arm 124 receives at least a portion of the post 132 .

[0057] The clamp 100 is configured to apply a force to at least the medial side of the first metatarsal 202 by manipulating the upper portion 110 such that the distance between the termini of the first arm 122 and the second arm 124 decreases when the interface portion 123 abuts the first metatarsal 202 from the medial side and the retaining element 125 engages the second metatarsal 204 from both the medial and lateral sides. Such force thus reduces the intramedullary angle between the first metatarsal 202 and the second metatarsal 204 by positioning at least a distal portion of the first metatarsal 202 closer to the second metatarsal 204 prior to the procedure. Additionally, the clamp 100 is configured such that a space remains between the first arm 122 and the second arm 124 when engaged as described above to allow manipulation of the big toe (e.g., the "hallux of the big toe"). Such manipulation may include repositioning the big toe to assess soft tissue or manipulating anatomical structures adjacent to the Lapidus joint.

[0058] 4-6, the clamp 100 is shown engaged with a foot 200. The interface element 123 is shown engaging a distal portion of the first metatarsal 202, while the retaining element 125 and a portion thereof engage a distal portion of the second metatarsal 204. As shown, the upper portion 110 of the clamp 100 can be manipulated to apply a force to the medial surface of the first metatarsal 202 such that the intramedullary angle formed between the central longitudinal axes of the first metatarsal 202 and the second metatarsal 204 is reduced. Once a desired correction to the intramedullary angle is achieved, the ratchet 116 can be engaged to hold the clamp 100 in the desired position such that the clamp 100 remains in a position that provides the desired correction.

[0059] 7-10, another clamp 300 is shown. The clamp 300 may be used for the same and / or similar procedures as the clamp 300 or other clamps illustrated and described herein. The clamp 300 includes an upper portion 310 (e.g., a handle, etc.) disposed substantially opposite the clamp 300 from a lower portion 320 (e.g., an engagement portion, a coupling portion, etc.). A coupling 318 is disposed between the upper portion 310 and the lower portion 320. The illustrated clamp 300 includes a pair of members pivotally coupled by the coupling 318, each member of the pair of members including at least a portion of the upper portion 310 and at least a portion of the lower portion 320. The ratchet 316 may be configured to adjust the clamp from a first position to a second position or to hold the clamp in a desired position (e.g., to maintain some desired correction). In some aspects, the coupling 318 can include a geometry that defines a range of movement for the upper portion 310 and / or lower portion 320 of the clamp 300, such as the illustrated ratchet or other coupling mechanism.

[0060] The clamp 300 includes a first arm 322 and a second arm 324, which are substantially symmetrical. Each of the first arm 322 and the second arm 324 includes an opening 321 at its distal end, which is disposed slightly plantar relative to (e.g., inferior to) the majority of the first arm 322 and the second arm 324. Each of the openings may be the same and / or similar to the openings shown and described with reference to the clamp 100. The openings 321 of the first arm 322 and the second arm 324 are configured to receive and pivotally and releasably couple a first retaining element 323 and a second retaining element 325 (which, as shown, are substantially the same components). The first and second retaining elements are configured to interface, engage and releasably couple to the first and second metatarsals 202 and 204, respectively, as previously shown and described.

[0061] 17-22, each of the retention elements 323, 325 is shown as a retention system 350, and each of the retention elements 323, 325 of the clamp 300 may be a retention system, similar to that shown as component 350. The retention system 350 includes a first element 360 and an actuator 370. The first element 360 includes a post 362 at an upper portion thereof (e.g., an upper portion) and includes a pair of engagement elements 366 disposed at a lower portion thereof (e.g., opposite the post 132). The illustrated post 362 includes a thread 363 disposed on at least a portion thereof. As shown, the thread 363 is disposed on a lower portion of the post 362. The illustrated engagement element 366 is a pair of prongs extending from a lower portion of the post 362 adjacent to a lower portion of the thread 363. The engagement element 366 includes a first segment extending perpendicularly from the lower portion of the post 362. The engaging element 366 further includes a second segment 368 that extends from the first segment and continues to a terminus of the engaging element 366. As shown, the second segments 368 are substantially parallel to one another. The inner surfaces of the second segments 368 (e.g., the inner surfaces that face one another) include a texture configured to induce friction upon contact with bone and promote bone retention therebetween.

[0062] The retention system 350 is shown to further include an actuator 370 configured to adjust the distance between the engagement elements 366 and further adjust the engagement elements 366 to position the engagement elements 366 adjacent to the second metatarsal 204 and ultimately initiate contact (e.g., engagement, releasable coupling, etc.) with the second metatarsal 204. The actuator 370 includes an aperture 372 configured to receive the post 362 therethrough. The aperture 372 further includes threads 373 disposed on an inner surface of the aperture 372 having a geometry complementary to the geometry of the threads 363 to facilitate a threadable and releasable coupling. The actuator 370 also includes a texture 374 disposed on an outer surface thereof to facilitate gripping and manipulation of the actuator 370. The actuator 370 is configured as follows: That is, when the first element 360 is positioned such that the engagement element 366 is positioned adjacent the second metatarsal 204, the actuator can be releasably coupled to the post 362 such that the threads 363 and 373 engage, causing the actuator 370 to move downward along the threads 363 of the post 362. When the actuator 370 begins to contact the engagement element 366, the force applied by the actuator 370 can drive the engagement elements 366 closer together. (E.g., the actuator 370 begins to receive at least a portion of the engagement element 370 within the opening 372 of the actuator 370, thereby driving the engagement elements 366 closer together and decreasing the volume of the space 365 therebetween). This causes the space 365 between the engagement elements 366 to decrease, and the medial and lateral surfaces of the second metatarsal 204 are gripped by the second segment 368 of the retention system 350. The clamp 300 may then be releasably coupled to the post 362 of the retention system 350 by positioning the clamp such that the openings in the first arm 322 and second arm 324 receive at least a portion of the post 362 .

[0063] The clamp 300 is configured to apply a force to at least the medial side of the first metatarsal 202 by manipulating the upper portion 110 such that the distance between the termini of the first and second arms 322, 324 is decreased when the first retaining element 323 of the first arm 322 is coupled to the first metatarsal 202 from both the medial and lateral sides and the second retaining element 325 of the second arm 324 is engaged to the second metatarsal 204 from both the medial and lateral sides. Such a force thus reduces the intramedullary angle between the first and second metatarsal 202, 204 by positioning at least a distal portion of the first metatarsal 202 closer (e.g., more laterally) to the second metatarsal 204 prior to the procedure. Additionally, the clamp 300 is configured such that a space remains between the first and second arms 322, 324 when engaged as described above to allow for manipulation of the big toe (e.g., the "hallux of the big toe"). Such manipulations may include repositioning the big toe to assess the soft tissue or manipulating the anatomical structures adjacent to the Lapidus joint.

[0064] 23-26, a cut guide system 400 is shown including a retention system 350 and a cut guide 410. It should be noted that the cut guide 410 may be implemented with the retention element 125 and the clamp 100. The cut guide 410 may include other embodiments (e.g., left / right counter parts, etc.) than those shown herein. As shown, the cut guide 410 includes a cutting portion 420 and a coupling portion 430, which is a protrusion from the cutting portion 420. The cut guide 410 is shown to releasably couple with the retention system 350 via the coupling portion 430 as follows: an opening 434 of the cut guide 410 receives the post 362 of the first element 360 (by extending from the top surface 432 through the coupling portion 430 to the bottom surface), and then the actuator 370 also receives the post 362, such that the cut guide 410 is positioned between the engagement element 366 and the actuator 370.

[0065] As shown, the incision 420 includes a number of incision slots 422 extending therethrough. The incision slots 422 shown are substantially the same size and extend substantially perpendicular to one another, but may have alternative geometries and arrangements in some aspects. In some aspects, the cut guide system 400 can be configured to position the incision slots 422 substantially parallel to another surface (e.g., parallel to the surface of the proximal first metatarsal 202 already cut so that a parallel incision is made to the distal first cuneiform bone 204 to create an ideal surface for fixation). The physician can determine which incision slots 422 are best positioned to make the desired incision, and once determined, the physician can use a reciprocating saw or other similar instrument to make the desired incision.

[0066] 17-24, a clamp 500 is shown. The clamp 500 may be similar to the clamps 100, 300 previously shown and described, and may be used for the same and / or similar procedures (e.g., treatment of the Lapidus joint). In some embodiments, the clamp 500 is manipulated such that one or more components of the clamp 500 contact one or more anatomical structures of the foot, and at least one of the anatomical structures is selectively repositioned by the physician upon application of force to the clamp by the physician. The clamp 500 includes an upper portion 510 (e.g., a handle, etc.) disposed substantially opposite the clamp 500 from a lower portion 520 (e.g., an engagement portion, a coupling portion, etc.) as shown in FIGS. 17-24. A coupling 518 is disposed between the upper portion 510 and the lower portion 520. The illustrated clamp 500 includes a pair of members pivotally coupled by the coupling 518, each member of the pair including at least a portion of the upper portion 510 and a portion of the lower portion 520. The locking mechanism 516 can be configured to adjust the clamp 500 from a first position to a second position or to hold the clamp 500 in a desired position (e.g., to maintain some desired correction). In some aspects, the coupling 518 can include a geometry that defines a range of movement of the upper portion 510 and / or lower portion 520 of the clamp 500, such as a ratchet as shown or other coupling mechanism.

[0067] The clamp 500 is further shown to include a first arm 522 and a second arm 524 extending from the coupling 518 at a lower portion 520 of the clamp. As shown, the first and second arms 522, 524 are integral with the first and second handle portions 512, 514 (the first handle portion 512 is integral with the second arm 524, and the second handle portion 514 is integral with the first arm 522). The first arm 522 is shown to include a bend disposed between the coupling 518 and an interface component 526, the interface component 526 being disposed at the terminus of the first arm 522. As shown, the interface component 526 is disposed substantially perpendicular (e.g., bent plantarly) to the first arm 522 between the coupling 518 and said bend (although some embodiments may have other arrangements). As shown at least in FIGS. 31-32 , the interface component 526 further has a curvature configured to accommodate the curvature of the medial portion of the first metatarsal 202. In some embodiments, the interface component 526 can be configured to interface with a distal portion of the first metatarsal 202. The interface component 526 may also include a textured surface 527 on at least one surface of the interface component 526 (e.g., a surface having a concave curvature to accommodate the first metatarsal 202) to promote prolonged contact with the surface of the first metatarsal 202 by increasing friction with the surface of the first metatarsal 202. The interface component 526 is also shown to include an opening 528 extending therethrough, the opening 528 being configured to receive a stabilization wire 529. The stabilization wire 529 may be a K-wire or, as shown, an olive wire with a depth stop (e.g., a portion of the wire having a diameter greater than the diameter of the opening 528). A stabilization wire 529 is inserted through the opening 528 and coupled to the first metatarsal 202 as shown, with the stabilization wire extending from the first metatarsal 202 at an oblique angle relative to the horizontal.

[0068] The second arm 524 is shown to include a retaining element 550 disposed at a terminal end of the second arm 524, the retaining element 550 being releasably coupleable with the second arm 524. As shown, the retaining element 550 includes a post 552 (seen at least in FIGS. 33-34 ) configured to be received in an opening of the second arm 524 (moving in a bottom-to-top direction of the foot). The retaining element 550 is configured, in some embodiments, at a distal portion thereof to facilitate coupling with the second metatarsal 204. The retaining element 550 is configured to be pivotable within the opening of the second arm 524 to facilitate coupling with the second metatarsal 204 despite various lateral geometries of the second metatarsal 204.

[0069] The retaining element 550 includes a first element 552 and a second element 560, as further shown in FIGS. 33-34. The first element 552 includes a post 555 at its upper portion (e.g., upper portion) and a pair of engagement elements 559, 563 disposed at its lower portion (e.g., opposite the post 555). The post 555 includes a thread (not shown) disposed on at least a portion thereof, which thread may be the same and / or similar to those shown in other similar embodiments previously disclosed herein. The thread is disposed on the lower portion of the post 555. The illustrated engagement elements 559, 563 are a pair of prongs extending from a lower portion of the post 555 adjacent the lower portion of the thread. The engagement elements 559, 563 include a pair of extensions 556, 557 extending perpendicularly from the lower portion of the post 555 (adjacent the thread). The engaging elements 559, 563 include a bend along a portion thereof (also at a right angle) and continue substantially parallel to one another between said bend and the respective termini of the engaging elements 559, 563. The inner surfaces of the engaging elements 559, 563 (e.g., the surfaces facing one another) include a texture configured to induce friction upon contact with bone and promote bone retention therebetween.

[0070] As shown, the retention element 550 further includes an actuator 560. The actuator 560 is configured to adjust the distance between the engagement elements 559, 563 to position the engagement elements 559, 563 adjacent to the second metatarsal 204, and ultimately further adjust the distance between the engagement elements 559, 563 to initiate contact (e.g., engagement, releasable coupling, etc.) with the second metatarsal 204. The actuator 560 includes an opening 553 configured to receive a post 555 therethrough. The opening 553 further includes threads disposed on an inner surface of the opening 553 having a geometry complementary to the geometry of the threads of the post 555 to facilitate a threadable and releasable coupling. The actuator 560 also includes a first texture 554 disposed on an upper portion of its outer surface to facilitate gripping and manipulation of the actuator 560. The actuator 560 also includes a second texture 562 (larger than the first texture 554). The second texture 562 extends around the periphery (e.g., or another outer dimension) of the actuator 560 and is disposed below the first texture 554 and below a recess disposed above the second texture 564. The actuator 560 is configured as follows: when the first element 552 is positioned such that the engagement elements 559, 563 are positioned adjacent the second metatarsal 204, the actuator can be releasably coupled to the post 555 such that the threads of the post and the opening 553 of the actuator 560 engage, causing the actuator 560 to move downward along the threads of the post 555. When the actuator 560 begins to contact the extensions 556, 557, the force applied by the actuator 560 can drive the extensions 556, 557 (and the engagement elements 559, 563) toward one another. (E.g., actuator 560 begins to receive at least a portion of extensions 556, 557 within opening 553 of actuator 560, thereby driving engaging elements 559, 563 closer together.) This causes the space between engaging elements 559, 563 to decrease, and the medial and lateral surfaces of second metatarsal 204 to be gripped by engaging elements 559, 563 of retention element 550.The clamp 500 can then be releasably coupled to the post 555 of the retaining element 550 by positioning the clamp such that the opening in the second arm 524 receives at least a portion of the post 555 .

[0071] The clamp 500 is configured to apply a force to at least the medial side of the first metatarsal 202 by manipulating the upper portion 510 such that the distance between the termini of the first and second arms 522 and 524 is reduced when the interface portion 526 abuts the first metatarsal 202 from the medial side and the retaining element 550 engages the second metatarsal 204 from both the medial and lateral sides. Such force thus reduces the intramedullary angle between the first and second metatarsals 202 and 204 by positioning at least a distal portion of the first metatarsal 202 closer to the second metatarsal 204 prior to the procedure. Additionally, the clamp 500 is configured such that a space remains between the first and second arms 522 and 524 when engaged as described above to allow manipulation of the big toe (e.g., the "hallux of the big toe"). Such manipulation may include repositioning the big toe to assess soft tissue or manipulating anatomical structures adjacent to the Lapidus joint.

[0072] 31-32, the clamp 500 is shown engaged with the foot 200. The interface element 526 is shown engaging a distal portion of the first metatarsal 202, while the retaining element 550 and a portion thereof engage a distal portion of the second metatarsal 204. As shown, the upper portion 510 of the clamp 500 can be manipulated to apply a force to the medial surface of the first metatarsal 202 such that the intramedullary angle formed between the central longitudinal axes of the first metatarsal 202 and the second metatarsal 204 is reduced. Once a desired correction to the intramedullary angle is achieved, the ratchet 516 can be engaged to hold the clamp 500 in the desired position such that the clamp 500 holds the position that provides the desired correction.

[0073] It should be noted that clamp 500 and its components may be the same and / or similar to those previously shown and described with reference to clamps 100 and 300, and may include components implemented in combination with clamps 100 and 300. For example, retaining element 550 may be substituted for retaining element 125, and vice versa. Similarly, retaining element 550 and its components may be configured to releasably couple with guide system 400 of Figures 23-26, or other similar guide or outrigger systems.

[0074] 35A-35B, a process or method 3000 for performing a surgical procedure, for example, fixation of a Lapidus joint (e.g., first tarsometatarsal joint, bunion correction procedure, etc.) is shown. The process 3000 and its steps may be performed in one or more orders different than the order shown in FIG. 35A-35B. Steps of the process 3000 may also be omitted, repeated, or performed in an order other than the order shown. In some aspects, the process 3000 may also include performing one or more additional steps not shown in FIG. 35A-35B.

[0075] According to some aspects, process 3000 includes step 3002, which involves making a first incision adjacent to the Lapidus joint of a patient. In some aspects, the incision of step 3002 may be made at a location substantially dorsal-medial to the Lapidus joint. Additionally, the incision of step 3002 may be made using one or more instruments (e.g., scalpels or other dissection instruments) provided as part of a surgical kit for performing the procedure as shown and described with reference to process 3000 and FIGS. 35A-35B.

[0076] According to some aspects, the process 3000 includes step 3004, which releases and prepares the patient's Lapidus joint via a first incision. Step 3004 can include various commonly performed steps and techniques for releasing and preparing a joint for an arthrodesis procedure such as process 3000. For example, step 3004 can include releasing the Lapidus joint so that the first metatarsal can be more easily manipulated in subsequent steps of the process 3000. In some aspects, an incision can be made at the base (e.g., proximal end) of the first metatarsal using the same or similar cutting guide as previously shown and described herein. It should also be understood that in some aspects, step 3004 can also include an incision made at the cuneiform bone, which incision at the cuneiform bone can be made before or after any incision to the first metatarsal bone. In some aspects, step 3004 may include an incision into the cuneiform bone, along with any incisions into the first metatarsal made in a previous or subsequent step. After making such incisions, a fragment of the first metatarsal (resulting from the incision) is removed from the joint space. The Lapidus joint and surrounding structures may also be evaluated after release of the joint and the aforementioned incisions, and general adjustments or further manipulations may be made to achieve the desired results. In some aspects, the distal portion of the first metatarsal may be further prepared, for example, by fenestration or other general techniques to prepare at least a portion of the joint space for fixation.

[0077] According to some aspects, the process 3000 includes step 3006, which involves making a second incision adjacent to the second metatarsal. The incision of step 3006 may be the same or similar (e.g., size, etc.) as the incision of step 3008. In some aspects, the second incision may be made from a substantially lateral position (e.g., direction, etc.) relative to the second metatarsal to facilitate access to the second metatarsal in subsequent steps of the process 3000. In some aspects, the incision of step 3006 may be made adjacent a distal portion thereof with reference to one or more anatomical structures, e.g., the second metatarsal. As shown and described herein, the second incision may be a "stab" incision, although other incision types and techniques may be performed by the physician.

[0078] According to some aspects, the process 3000 includes step 3008, which involves making a third incision adjacent to a dorsal portion of the first metatarsal. In some aspects, the incision of step 3008 can be made at a distal portion of the first metatarsal (e.g., adjacent to the head of the first metatarsal), and thus can be made substantially opposite the first metatarsal from the direction of the first incision (distal-proximal). In some aspects, the third incision can be made from a substantially medial direction relative to the head of the first metatarsal to facilitate access to and manipulation of the first metatarsal in subsequent steps of the process 3000. The third incision of step 3008 can be made adjacent to (and at least access to) the dorsal, lateral, and proximal portions of the head of the second metatarsal (where the head is the distal portion of the second metatarsal). The incisions of steps 3006 and 3008 may be at least partially in one plane in the frontal plane (e.g., each substantially equidistant from the proximal-most portions of the first and second metatarsals, respectively).

[0079] According to some aspects, the process 3000 includes step 3010, which releasably couples a first portion of a retaining element to the second metatarsal through a second incision. When releasably coupling the first portion of the retaining element, the physician approaches the second metatarsal dorsally (e.g., from above) with the first portion of the retaining element in the second incision. The first portion of the retaining element is then inserted until the engagement elements 559, 563 (e.g., prongs, projections, extensions, etc.) contact (or are positioned directly adjacent to) the medial and lateral surfaces (e.g., flats of the lateral portion of the second metatarsal). The first portion of the retaining element may be, for example, at least the engagement element 556 of the retaining element 550 as shown in FIGS. 33-34, or may include other similar portions of other retaining elements previously shown and described herein. In some aspects, step 3010 can include identification and / or manipulation of the extensor tendon by the physician to position a first portion of the retention element.

[0080] According to some aspects, the process 3000 includes step 3012, which releasably couples a retaining element with a first arm of a surgical clamp. Step 3012 can include clamp 500 as shown and described herein, as well as other clamps, including but not limited to those described herein. Step 3012 includes aligning a first arm of a surgical clamp, e.g., a first arm of said surgical clamp (which can correspond to second arm 524 of clamp 500), where the nomenclature of the first and second arms of the clamp may be arbitrary, and where the surgeon manipulates the first arm of the clamp such that an opening (e.g., opening 530 of clamp 500) is shaped to be complementary to the geometric shape of the upper portion of the retaining element (e.g., post 555 of retaining element 500). The opening includes a geometric shape that is complementary to the geometric shape of the upper portion of the retaining element (e.g., post 555). The top of the retaining element, when releasably coupled to the clamp, can extend into and at least partially through the opening of the clamp from a downward-upward direction (e.g., when the clamp and retaining element are releasably coupled, the clamp and opening are disposed above the top of the retaining element).

[0081] According to some aspects, the process 3000 includes step 3014, which releasably couples a second portion (also referred to as a cap portion) of the retaining element to a first portion of the retaining element. In some aspects, step 3014 may include releasably coupling the cap portion of the retaining element to a top portion of the retaining element to hold the distal portion of the first arm of the clamp substantially between the engagement element and the cap portion (and the top of the top portion of the retaining element). To facilitate coupling of the cap portion to the top portion of the retaining element (e.g., the top portion of the post), the cap portion may include an internal thread complementary to an external thread disposed on the top portion of the post. The cap portion may be disposed above the top portion of the post and coupled via the aforementioned threads such that at least a portion of the post is disposed within the cap portion when the two components are coupled. In the coupled position, the cap portion may be disposed in contact with or adjacent to an upper surface of the distal portion of the first arm.

[0082] Referring now to FIG. 35B , according to some embodiments, the process 3000 includes step 3016, which positions a portion of the second arm of the surgical clamp adjacent to the first metatarsal through a third incision. In some embodiments, a third incision as described in the process 3000 may not be made, in which case step 3016 may include positioning a portion of the second arm of the surgical clamp adjacent to the first metatarsal but outside the skin. The second arm of the clamp (e.g., clamp 500 shown and described herein) may correspond to the first arm 522 of the clamp 500, where the nomenclature of the first arm and second arm is arbitrary. With respect to step 3016, the second arm of the clamp may include one or more interface portions at its distal portion, which extend at an orthogonal or perpendicular angle in a substantially dorsal (e.g., inferior) direction from a central portion of the second arm. In step 3016, the interface portion may be positioned adjacent to or in contact with a medial portion of the first metatarsal by inserting it through the third incision (formed in step 3008). The interface portion may have a curvature along at least a portion thereof, and step 3016 may include positioning said curvature relative to the medial curvature of the patient's first metatarsal. Step 3016 may further include positioning the interface portion such that an opening in the interface portion (e.g., the same as or similar to opening 528 in clamp 500) is visible by the physician through or adjacent to the third incision.

[0083] According to some aspects, the process 3000 includes step 3018, which includes inserting a first stabilization wire (e.g., K-wire, olive wire, rotating wire, lever wire, stabilization member, rotating member, etc.) into the first metatarsal through a first incision. The first stabilization wire may be a conventional K-wire, olive wire, or other stabilization wire commonly known and used in similar procedures. When inserted into the first metatarsal (its proximal portion), the first stabilization wire may protrude from the first metatarsal in a dorsal-medial direction. In some aspects, the physician may determine the placement of the first stabilization wire in the dorsal-medial direction based on an estimate of the desired derotation of the first metatarsal. For example, if a large angle of derotation is desired, the first stabilization wire may be placed more medial than dorsal, while if a small angle of derotation is desired, the first stabilization wire may be placed more dorsal than medial.

[0084] According to some aspects, process 3000 includes step 3020, which derotates the first metatarsal. As mentioned above, step 3020 can be performed simultaneously with step 3022, described below. Additionally, in some aspects, steps 3020 and 3022, if not performed simultaneously, may be performed in an alternating order. In performing step 3020, the physician manipulates the first stabilization wire placed in step 3018 such that the first metatarsal rotates counterclockwise about its central longitudinal axis when viewed from the distal portion of the first metatarsal. To rotate the first metatarsal, the physician grasps the first stabilization wire and applies force thereto, using the first stabilization wire as a lever to rotate the first metatarsal with this force. In some aspects, this may be done while the intramedullary angle described in step 3022 is being reduced. In some aspects, the physician may perform step 3020 with one hand while maintaining the desired intramedullary correction achieved in step 3022. The first stabilization wire can also be manipulated by the physician through the implementation of tools (eg, components that aid in gripping the first stabilization wire and / or applying force to the first stabilization wire).

[0085] According to some aspects, the process 3000 includes a step 3022, which reduces the intramedullary angle between the first and second metatarsals. It is noted that in many surgical procedures, steps 3020 and 3022 can be performed simultaneously, and in some aspects, it may even be advantageous for the surgeon to perform these two steps simultaneously. Step 3022 may include manipulating a handle portion of the clamp (e.g., handle portion 510 including at least one of handle elements 512, 514 of clamp 500) to move a distal portion of the first metatarsal closer to the second metatarsal (e.g., moved laterally by an interface portion of the first metatarsal arm with a lateral force applied thereto), thereby reducing the intramedullary angle formed between a longitudinal axis extending along the first and second metatarsals. In some aspects, the second metatarsal may also be manipulated. In some aspects, only the first metatarsal may be repositioned while the second metatarsal remains stationary.

[0086] According to some aspects, the process 3000 includes step 3024, which inserts a second stabilization wire through a through hole in the clamp and into the first metatarsal through the third incision. In some aspects, if a third incision is not made, the second stabilization wire may be inserted percutaneously. The second stabilization wire in step 3024 may be the same as or similar to the stabilization wire 529 shown and described with reference to the clamp 500. The location of the interface portion in step 3016 aids in the performance of step 3024, since the location of the opening 528 near the third incision allows the physician to insert the second stabilization wire into the opening in the interface portion (e.g., the same as or similar to the opening 528) and into the first metatarsal through the opening. Once coupled to the first metatarsal of the patient through the opening in the interface portion and engaged with the clamp, the second stabilization wire may be held in a desired position by the features of the clamp. Additionally, in some embodiments, the second stabilization wire may be an olive wire (possibly a threaded olive wire) that includes a depth stop (e.g., a portion on the shaft of the wire that has a diameter larger than the diameter of the opening in the interface portion of the clamp).

[0087] According to some aspects, the process 3000 includes a step 3026, which releasably couples one or more guide instruments to the retaining element. The guides in step 3026 may include the guides shown and described in FIGS. 23-26 or may include other alternative cut guides. The guides in step 3026 may be configured to releasably couple to a cap portion and / or other portion of the retaining element such that the guides can be coupled and positioned while the clamps remain engaged with the first and second metatarsals. The guide instruments may include a guide configured to guide one or more incisions to the medial cuneiform bone, which may reference the second metatarsal bone and / or other adjacent anatomical structures. In some aspects, the guide instruments are configured to guide an incision to a distal surface of the medial cuneiform bone, which is substantially parallel to a surface of a proximal portion of the first metatarsal bone after an incision was previously made in the process 3000 (to prepare and release the joint).

[0088] According to some aspects, the process 3000 includes step 3028, which performs one or more incisions on the patient's medial cuneiform bone to prepare the joint space for fixation. As noted in step 3026, the incision of step 3028 can be guided by a guide instrument such that the incision is made on the medial cuneiform bone such that the distal surface of the resulting medial cuneiform bone is substantially parallel to the proximal surface of the already prepared first metatarsal bone. The incision of step 3026 can be made using a reciprocating saw or other similar instrument commonly used when making similar incisions in similar surgical procedures. After performing the incision of step 3028, the guide instrument can be removed from the cap portion and / or the retaining element. The joint space of the Lapidus joint may also be prepared for fusion (e.g., fenestrated surface, etc.).

[0089] According to some aspects, the process 3000 includes step 3030, which applies a fixation device across the lapidus joint. Step 3030 also includes positioning the first metatarsal and medial cuneiform in a desired orientation for fixation. To achieve this orientation, the physician can dorsiflex the big toe (e.g., "hallux") to engage the Windlass Mechanism and place the big toe between the arms of the clamp (the arms of the clamp are designed to leave space for the big toe to dorsiflex). The physician then places third and fourth stabilization wires across the joint to stabilize the joint. Once these third and fourth stabilization wires are in place, a fixation device (e.g., plate, fixation device, etc.) is applied across the joint and coupled to both the first metatarsal and medial cuneiform. After the fixation device is secured, the clamp is removed (including the second stabilization wire) and the incision is closed.

[0090] It should be noted that the steps of process 3000 may be performed in a different order, steps may be added, steps may be omitted, steps may be repeated, or may be otherwise modified when performing a Lapidus treatment procedure as illustrated and described herein. For example, before securing the fixation devices to the first metatarsal and first cuneiform, the physician may manipulate the surrounding structures to ensure that the structures maintain functional and structural stability and otherwise provide the necessary balance for the patient. Similarly, in some aspects, one or more incisions may be made in the first metatarsal and / or medial cuneiform. For example, the physician may make a first incision and determine that a greater amount of bone needs to be removed, and then make a second incision using the same or a second guide instrument. In another exemplary procedure, process 3000 may be modified such that the physician makes an incision (the same as or similar to the incision previously described herein) in the first metatarsal and medial cuneiform before applying a surgical clamp (e.g., as illustrated and described herein). Incisions into the first metatarsal and medial cuneiform bone can be made using one or more cutting guides as shown and described herein (or other similar cutting guides) that are angled to guide the incisions to achieve the desired correction. Application of a surgical clamp can be performed (and the clamp operated as described herein) to achieve the desired correction of the joint, and a fixation device (intramedullary nail, plating, etc.) can be applied before removal of the surgical clamp.

[0091] 36-38, a system 3100 for positioning an orthopedic implant according to the present disclosure is shown. As shown, the system 3100 includes a positioning mechanism 3102 configured to facilitate positioning of one or more orthopedic implants (e.g., plates, intramedullary nails, other orthopedic implants, and / or fixation devices, etc.), such as the illustrated implant 3112. The positioning mechanism 3102 can be configured to releasably or otherwise couple with the implant 3112. This facilitates insertion through an opening in the skin and / or intraoperative manipulation of the implant 3112 and / or a portion of the anatomical structure. In some aspects, the system 3100 can be configured to cause a particular portion of the anatomical structure to receive the implant (e.g., the positioning mechanism 3102 can have one or more features / components that facilitate coupling with a particular implant to a particular anatomical structure). The system 3100 can also include components in addition to those shown in the exemplary embodiment of FIGS. 36-38. For example, fasteners (e.g., screws, etc.), alignment guides, drills / drill bits, and other components common to orthopedic systems are included. Similarly, system 3100 (or one or more components thereof) may be implemented in conjunction with other systems. For example, alignment mechanism 3102 may be implemented with a variety of implants, alignment systems, or other hardware or software components.

[0092] Although the deployment mechanism 3102 is shown to include a body 3103 having a substantially cylindrical shape, the body 3103 may have alternative geometries and dimensions in other embodiments. In some aspects, the body may include a textured exterior surface or alternative exterior geometries (e.g., exterior geometries with texture or ergonomic features for ease of gripping). The body 3103 includes a cannulated portion, as shown in cross-section in FIG. 38. The cannulated portion extends from the first end 3104 of the body to the second end 3108 of the body about the longitudinal axis of the body 3103. The cannulated portion of the body 3103 terminates in an opening 3106 at the first end 3104 and similarly terminates in an opening at the second end 3108 (not shown). In some aspects, the body 3103 may be substantially symmetrical in cross section about the longitudinal axis of the body 3103 and / or about a midline disposed between the first end 3104 and the second end 3108 extending perpendicular to the cannulation of the body 3103. The shape and dimensions of the cannulation may vary with some embodiments of the system 3100. For example, the cannulation of the body 3103 may be configured to receive one or more other components, such as fixation / stabilization wires, fasteners, drills and / or drill bits, alignment guides, or other instruments and components common to orthopedic surgical procedures. Additionally, the positioning mechanism 3102 may be maneuverable about one or more components at least partially disposed within the cannulation of the body 3103. For example, a stabilization wire may be disposed within the cannulation of the body 3103 (and extend through a portion of the implant 3112) and coupled to at least a portion of the bone. This allows the deployment mechanism to be detached from any implants (if coupled to any such implants) and withdrawn over the stabilization wire. In some embodiments, the system 3100 may include components sized such that they are received by and manipulable within a cannulated portion of the body 3103.

[0093] The positioning mechanism 3102 is further shown to include a coupling mechanism 3110 extending from the second end 3108 of the body 3103. As shown, the coupling mechanism 3110 includes a pair of extensions disposed substantially diametrically opposite one another at the second end 3108 of the body 3103, each of the pair of extensions extending from an outer surface of the second end 3108. It should be understood that alternative embodiments of the system 3100, and / or any components thereof, may include alternative coupling mechanisms similar to the illustrated coupling mechanism 3110. For example, the coupling mechanism 3100 may include other or fewer extensions, the extensions may be arranged in other configurations than those of the exemplary embodiment of FIGS. 36-38, and the extensions may have alternative shapes (e.g., longer / shorter lengths, curvatures, radii of curvature, etc.). In some aspects, the coupling mechanism 3110 (including some or all of any extensions or any other components such as those shown and described herein) may otherwise extend from the body 3108. For example, the coupling mechanism 3110 and any components thereof (e.g., extensions) may be integral with the body 3103 or may extend from the second end 3108 adjacent an opening in the second end 3108 where the cannulation portion of the body 3103 terminates.

[0094] As shown in FIGS. 36-38 , the system 3100 includes a positioning mechanism 3102 releasably coupled to the second metatarsal 3150 via a coupling mechanism 3110. The system 3100 further includes an implant 3112, shown as a plate in the exemplary embodiment of FIGS. 36-38 , disposed between a second end 3108 of the positioning mechanism 3102 and a top surface of the second metatarsal 3150. The implant 3112 is intended to be exemplary, as the system 3100 can include a variety of implants of alternative sizes and / or geometries. Similarly, the system 3100 and its components can be implemented in the treatment of portions of the anatomy other than the second metatarsal (e.g., other bones of the foot, ankle, hand, wrist, etc.). For example, the positioning mechanism 3102 and its components may have alternative geometries (e.g., longer coupling mechanisms, etc.) to couple with larger / smaller implants and portions of the anatomy. In some aspects, the implant 3112 may be releasably coupled to the positioning feature 3102 via one or more coupling mechanisms (e.g., the geometry of the coupling mechanism 3110 may hold the implant 3112 adjacent the second end 3108 of the positioning mechanism 3102 via one or more of a notch, a compression fit, or other known coupling configurations). The positioning mechanism 3102 (whether the implant 3112 is releasably coupled or not) may be releasably coupled to the second metatarsal 3150 from a substantially dorsal direction (as shown), with the positioning mechanism 3102 being pressed down onto the top surface of the second metatarsal 3150. In alternative embodiments and alternative geometries, the positioning mechanism 3102 may be positioned, positioned, and / or coupled in other manners. In some aspects, the coupling mechanism 3110 (and any components thereof) may receive the second metatarsal 3150 to releasably couple thereto.In some aspects, the coupling mechanism 3110 (and its components) may be flexible or otherwise manipulable and have a geometric configuration that presses against the positioning mechanism 3102 and manipulates the coupling mechanism 3110 such that the coupling mechanism 3110, pressed down onto the top surface of the second metatarsal 3150, extends at least partially around the second metatarsal 3150.

[0095] The positioning mechanism 3102 can be grasped by the physician at the body portion 3103 and manipulated relative to the second metatarsal 3150. For example, the physician can manipulate the positioning mechanism 3102 similar to a joystick (e.g., distal, proximal, medial, lateral movements to reposition the positioning mechanism 3102 and implant 3112 about the surface of the second metatarsal 3150) with the positioning mechanism 3102 and implant 3112 translatable about the surface of the second metatarsal 3150. Once the desired position is reached, the physician can insert a stabilization wire through the opening 3106, into the cannulated portion of the body 3013, through the opening in the implant 3100, and into the second metatarsal 3150. This can hold the positioning mechanism 3102 and implant 3112 against the second metatarsal 3150. Once the stabilization wire is placed, the physician can again manipulate the positioning mechanism 3102 (similar to using a joystick) to manipulate the second metatarsal 3150 (since the system 3100 is coupled to the second metatarsal 3150). The physician can then remove the positioning mechanism 3102 on the stabilization wire (which disengages the positioning mechanism 3102 from the second metatarsal 3150). Alternatively, the physician may implement additional surgical instruments (e.g., cannulated drills, fasteners, etc.) on the stabilization wire and within the cannulated portion of the body 3103 to further the ongoing procedure. Eventually, the stabilization wire is removed before the procedure is completed. This process may be repeated multiple times using different instruments and components. As shown, the positioning mechanism 3102 is coupled to the end of the implant 3112 adjacent to the end opening of the implant 3100. However, the positioning mechanism 3102 may be releasably coupleable to the implant 3112 at various points along the length of the implant 3112, such as at each opening in the implant 3112. Thus, a physician may releasably couple and decouple the positioning mechanism 3102 to the implant 3112 multiple times at multiple locations along the implant 3112 and perform the same or similar surgical steps as described above at each respective coupling location.In some aspects, a physician may implement multiple systems 3100 and / or components thereof in a single procedure, for example, two placement mechanisms 3102 simultaneously coupled to a single implant 3112, or two systems 3100 each releasably coupled to a different bone or portion of a bone.

[0096] 39-54, an exemplary embodiment of a system 4100 is shown that may be implemented when performing a procedure on one or more anatomical structures of the foot (e.g., a procedure on the Lapidus joint, such as an arthrodesis or other similar fixation procedure). The system 4100 may include a clamp 4102 as shown and described herein with reference to FIGS. 39-54, and one or more other components, such as one or more surgical guides as shown and described herein. Furthermore, the system 4100 may be implemented in performing one or more steps of the method shown and described with reference to FIG. 66. Furthermore, it should be understood that the system 4100 may include one or more additional components (e.g., a dissection instrument, a saw, a scalpel, forceps, a retractor, etc.) in addition to those shown and described herein, and the method shown and described with reference to FIG. 66 may incorporate said additional components.

[0097] 39-54 illustrate an exemplary instrument, shown as a clamp 4102, for determining, aligning / realigning, correcting, positioning / repositioning, rotating / derotating, or otherwise manipulating one or more anatomical structures of the foot relative to other anatomical structures of the foot. As shown and described herein, the clamp 4102 is configured to releasably couple to structures of the foot 4200 (shown as 4200), including a first metatarsal (shown as 4202) and a second metatarsal (shown as 4204), as shown and described in FIGS. 47-53, thereby manipulating a Lapidus joint (shown as 4208) configured between the first metatarsal 4204 and the medial cuneiform (shown as 4206). In some aspects, the clamp 4102 may be mounted to a distal portion of the first metatarsal 4202 and the second metatarsal 4204, but may also be mounted elsewhere about the first metatarsal 4202 and the second metatarsal 4204. The clamp 4102 (and its components) is configured to facilitate correction of an IM angle formed between a first extended longitudinal axis of the first metatarsal 4202 and a second extended longitudinal axis of the second metatarsal 4204. Additionally, the clamp 4102 is configured to facilitate derotation of the first metatarsal 4202 relative to the second metatarsal 4204 (e.g., a rotation opposite to the rotation that caused the hallux valgus or other deformity). Correction of the IM angle and / or derotation of the first metatarsal 4202 relative to the second metatarsal 4204 can be performed by a physician in procedures to address deformities at or near the Lapidus joint (e.g., hallux valgus, Lapidus joint arthrodesis, etc.).

[0098] The clamp 4102 includes a first portion 4104 and a second portion 4106, as shown, where the first portion 4104 is releasably coupled to the second portion 4106 by or at a coupling 4108. In some aspects, the coupling 4108 may include a coupling mechanism (e.g., threads and a complementary bore, etc.), where a first component of the coupling is coupled or integral with the first portion 4104 and a second component complementary to the first component is coupled or integral with the second portion 4106. Further, in some aspects, the coupling 4108 may include a portion of the coupling mechanism, where at least a portion of the coupling mechanism is configured to extend at least partially within the second portion 4106. Such a portion of the coupling mechanism may be coupled or integral with the first portion 4104 and may further extend at least partially within an opening in the second portion 4106. In some aspects, at least a portion of the coupling may include incremental markers (e.g., indicators, measurement markers, etc.) that indicate expansion of the clamp 4102. The coupling 4108 (and any components thereof) may also facilitate movement of the first portion 4104 relative to the second portion 4106 or facilitate movement of the second portion 4106 relative to the first portion 4104. In some aspects, an actuator 4124 (e.g., a knob, etc.) disposed substantially along a longitudinal axis of the second portion 4106 may be configured to releasably couple with a portion of the second portion 4106 of the clamp 4102. For example, the actuator 4124 may include a protrusion (e.g., a male component with threads, a set screw, etc.) that extends longitudinally into and through a bore disposed in the second portion 4106 of the clamp to facilitate releasable coupling of the coupling 4108 with the first portion of the clamp 4104 (e.g., complementary threads, etc.). In some aspects, the bore may include a coupling mechanism therein (e.g., a thread, etc.) configured to releasably couple with a complementary portion of the actuator 4124 (e.g., the protrusion, which may have a coupling mechanism such as a thread).Thus, manipulation of the actuator 4124 via the texture 4126 (e.g., to facilitate gripping, rotation, manipulation, etc.) can translate the second portion 4106 toward or away from the first portion 4104 to expand the clamp 4102. In some aspects, the translation can be along a shared (e.g., common) longitudinal axis by one or more of the actuator 4124, the protrusion from the actuator 4124, the bore of the second portion 4106, and any complementary coupling features of the first portion 4104. Additionally, the first portion 4104 and the second portion 4106 can be coupled such that one or both of these portions are operable about a longitudinal axis (e.g., a shared / common axis).

[0099] As shown, the second portion 4106 of the clamp 4102 includes a pair of projections 4118 extending laterally from the second portion 4106. As shown in FIGS. 39-54, the projections 4118 are positioned along the second portion 4106 such that the pair of projections are equidistant from the coupling 4108 and are further positioned closer to the actuator 4124 than the coupling 4108. In some aspects, the actuator 4124 may include at least a portion of a coupling feature configured to be complementary to the coupling feature of the coupling 4108. For example, the actuator 4124 may include an extension having threads configured to be received within at least a portion of the coupling 4108. In some aspects, the extension of the actuator 4124 may be configured to releasably couple the second portion 4106 with the first portion 4104 via the coupling 4108. Although the projections 4118 are shown to be substantially hemispherical, in some aspects of the clamp 4102, the projections 4118 may have alternative geometric shapes. Each prong is shown to include a bore 4120 having a substantially cylindrical shape and extending from a top surface to a bottom surface of the second portion 4106 and establishing fluid communication therebetween. The bore 4120 can be configured to receive one or more common surgical instruments, such as stabilization wires, K-wires, olive wires, and / or other stabilization elements, to releasably couple the second portion 4106 with the second metatarsal 4204.

[0100] As shown in FIGS. 47-53, the stabilization wire may be positioned such that the wire is received in the bore 4120, and the wire may be inserted into a substantially dorsal portion of the second metatarsal 4204 (positioned closer to the proximal end of the second metatarsal 4204 than the distal end, as shown in FIGS. 47-53). For example, as shown in FIG. 50, one of the bores 4120 is shown receiving the second stabilization wire 4148, and the second of the two bores 4120 is shown empty. In some embodiments, the physician may choose to place a stabilization wire (such as the second stabilization wire 4148) in one / either of the bores 4120, rather than placing a stabilization wire in each of the bores 4120. When releasably coupled to the second metatarsal 4204 via a stabilization wire received through the bore 4120, the second portion 4106 of the clamp 4102 can be configured to be in a resting position when the actuator 4124 is manipulated to translate the first portion 4104 toward the second portion (e.g., the second portion 4106 secured to the second metatarsal 4204 remains stationary while the actuator 4124 translates the first portion 4104 toward the second portion 4106 and the second metatarsal 4204). In some aspects, the multiple bores 4120 may have different sizes (e.g., both large, both small, or one large / one small) and / or geometric shapes (e.g., rectangular, triangular, etc.) to accommodate corresponding geometries of various stabilization elements. Although each of the pair of protrusions 4118 is shown as having an equal size, in some embodiments, the second portion 4106 of the clamp 4102 may include one, two, or more protrusions that are the same or similar to the protrusions 4118 (having equal or different sizes) that are variously disposed along the second portion 4106. Additionally, in some embodiments, one or more of the protrusions 4118 may include zero, one, two, or more bores that are variously disposed about the circumference of the protrusions 4118. As shown, each of the bores 4120 is disposed substantially equidistant from the outer edge of the protrusions 4118, although in some embodiments of the clamp 4102, the bores 4120 may be disposed in an alternating manner.

[0101] As shown, the second portion 4106 of the clamp 4102 includes an extension 4110 configured on an opposite side of the second portion 4106 from the coupling 4108. The extension 4110 extends from the second portion 4106 at an angle substantially perpendicular to the second portion 4106 at a location adjacent the actuator 4124, as shown in FIGS. 39-54. As shown, the extension 4110 has a substantially rectangular cross-sectional shape, although in some embodiments of the system 4100, the extension 4110 may have alternative shapes. The extension 4110 includes a retention feature 4114, shown in FIGS. 39-54 as a pair of protrusions disposed at a distal end of the extension 4110 (e.g., opposite the second portion 4106 adjacent the actuator 4124), defining a cavity 4116 disposed substantially between the pair of protrusions of the retention feature 4114. As shown, the retention feature 4114 is integral with the extension 4110 and is substantially curved toward the first portion 4104 of the clamp 4102 (e.g., adjacent a tangent to said curvature that is substantially perpendicular to the second portion 4106). A distal-most portion of the retention feature 4114 faces substantially toward the first portion 4104 of the clamp 4102. The cavity 4116 is shown as having a substantially semi-elliptical geometry, which is disposed at a proximal-most portion of the cavity 4116. However, in some aspects, the cavity 4116 (and retention feature 4114) may have alternative thickness / width, length, depth, curvature, and other geometric characteristics.

[0102] The extension 4110 and the retaining feature 4114 are configured to at least partially interface (e.g., engage, contact, etc.) with a plateau of the second metatarsal 4204 disposed substantially laterally of the second metatarsal 4104, as shown in FIGS. 47-53. The retaining feature 4114 can be configured to contact a substantially lower portion of the plateau on the side of the second metatarsal 4204, including its distal-most portion. As shown, the curvature of the distal-most portion of the retaining feature 4114 is configured to at least partially surround the second metatarsal 4204. This causes the retaining feature 4114 to contact at least a portion of the plantar surface of the second metatarsal 4204 (and thus engage multiple surfaces of the second metatarsal 4204). In this manner, the curvature of the retaining feature 4114 accommodates the geometry of the second metatarsal 4204. This allows a force to be applied to the second metatarsal 4204 via the retaining feature 4114 (e.g., a force applied medially and / or superiorly to the lateral and / or plantar surface of the second metatarsal 4204) to maximize engagement of the retaining feature 4114 with the second metatarsal 4204. Thus, the retaining feature 4114 applies more force to the second metatarsal 4202 (e.g., the extension 4110 and / or the retaining feature 4114 contacts the second metatarsal 4204 in conjunction with manipulation of the actuator 4124 to translate one or both of the first portion 4104 and the second portion 4106 toward or away from one another) to maximize engagement of the extension 4110 of the second portion 4106 of the clamp 4102 with the second metatarsal 4204 and reduce / prevent loss of contact / engagement between the clamp 4102 and the second metatarsal 4204. In some aspects, the cavity 4116 can be configured to receive (eg, allow the passage of) one or more stabilization wires.

[0103] The first portion 4104 of the clamp 4102 is shown having a substantially curved geometric shape (e.g., convex), with the curvature of the first portion 4104 pointing substantially toward the second portion 4106. The first portion 4104 includes an aperture 4130 disposed substantially at the distal portion 4128 (e.g., distal half) of the first portion 4104. The aperture 4130 is shown in FIGS. 39-54 to have an elongated round geometric shape (e.g., elliptical, oval, etc.) and has the same curvature as the first portion 4104. The aperture 4130 is disposed within an inner recess 4133 on the concave side and an outer recess 4134 on the convex side of the first portion 4104. The inner recess 4133 and the outer recess 4134 are shown to have similar depth, length, and width dimensions, with the inner recess 4133 and the outer recess 4134 having a greater length and width than the opening 4130 having the same / similar geometric shape. Further, the inner recess 4133 and the outer recess 4134 are disposed at approximately the same location on each surface of the distal portion 4128 of the first portion 4104.

[0104] The first portion 4104 is further shown to include an actuator 4136 having a first portion 4138 and a second portion 4140 separated by a connector 4139. As shown, the connector 4139 has a cross-sectional shape that is substantially smaller than the cross-sectional shape of the first portion 4138 or the second portion 4140. In some aspects, the connector 4139 may include an extension having at least a portion of a coupling feature (e.g., a thread) configured to be complementary to an opening disposed substantially along the longitudinal axis of the first portion 4138. Such a coupling feature may thus facilitate a releasable coupling between the first portion 4138 and the second portion 4140 of the actuator 4136. As shown in FIGS. 39-54, the connector 4139 has a substantially cylindrical geometry with a diameter / lateral dimension slightly smaller than the diameter / lateral dimension of the opening 4130. As shown in FIGS. 39-54, the first portion 4138 has a substantially cylindrical shape with a diameter slightly less than the width of the outer recess 4134. As shown, the second portion 4140 also has a lateral dimension slightly less than the width of the inner recess 4133. As shown in FIGS. 39-54, the connector 4139 is disposed such that at least a portion of the connector 4139 is disposed within the opening 4130. Similarly, a distal-most portion of the first portion 4140 is disposed within the outer recess 4134 and a distal-most portion of the second portion 4140 is disposed within the inner recess 4133. Thus, the range of movement of the actuator 4136 is defined by the dimensions of the opening 4130 (and, in some aspects, the inner recess 4133 and the outer recess 4134). The actuator 4136 is manipulated through a defined range of movement along the curvature of the first portion 4104. The boundaries of said range of movement are defined by the opening 4130 (and, in some aspects, the inner recess 4133 and / or the outer recess 4134). The actuator 4136 also includes a texture 4142 on an outer surface of a first portion 4138 of the actuator 4136, the texture being configured to facilitate gripping and / or manipulating the actuator 4136 (e.g., rotating it through a range of motion, etc.).

[0105] The actuator 4136 includes a bore 4144 extending along a longitudinal axis of the actuator 4136 from the first portion 4138, through the connector 4139, to the second portion 4140 such that fluid communication is established over the length of the actuator 4136. As shown in FIGS. 39-54 , the bore 4144 has a substantially cylindrical geometry configured to receive a stabilization wire (e.g., a K-wire, olive wire, etc.) that can pass through and within the bore 4144 of the actuator 4136. With reference to FIGS. 47-53 , a first stabilization wire 4148 can be received by the bore 4144 and inserted (e.g., releasably coupled) to the first metatarsal 4202 (as shown, a substantially medial portion of the first metatarsal 4202). Thus, when the first stabilization wire 4146 is positioned within the first metatarsal 4202, the actuator 4136 is releasably coupled to the first metatarsal 4202. By manipulating the actuator 4136 within a range of movement defined by movement of the connector 4139 within the aperture 4130, the first metatarsal 4202 is moved accordingly.

[0106] 47 shows the actuator 4136 releasably coupled to the first metatarsal 4202 via the first stabilization wire 4146, with the actuator 4136 in a first position 4150. The actuator 4136 is coupled such that a distal-most surface of the second portion 4140 of the actuator 4136 is located at or near a surface of the first metatarsal 4202 (substantially the medial surface, as shown). As shown, in the first position 4150, the connector 4139 of the actuator 4136 is in a bottom-most position within the opening 4130 such that a portion of the connector 4139 abuts the edges of the medial and lateral recesses 4133, 4134 (thus the first portion 4138 of the actuator 4136 is at the bottom of the lateral recess 4134, and the second portion 4140 of the actuator 4136 is at the bottom of the medial recess 4133). Manipulation of the actuator 4136 substantially upward from the first position 4150 to the second position 4152 (as shown in FIG. 48 ) rotates (or counter-rotates) the first metatarsal 4202 substantially about its longitudinal axis. For example, to correct some of the deformities or other problems of the Lapidus joint 4208 (or its components, such as the rotated first metatarsal 4202), the physician can manipulate the actuator 4136 from the first position 4150 to the second position 4152. In this manner, rotate / derotate the first metatarsal 4202 in the frontal plane, thereby correcting the rotational deformity of the first metatarsal 4202. In some aspects, the actuator 4136 may be in a third position between the first position 4150 and the second position 4152 when coupled to the first metatarsal 4202 by the first stabilization wire 4146. Similarly, in some aspects, the actuator 4136 may be manipulated by the physician, for example, from the third position discussed above to a fourth position, such as between the third position and the second position 4152. When the actuator 4136 is manipulated using the texture 4142, a set of notches 4132 in the outer recess 4134 are visible. The notches 4132 indicate incremental movement as the actuator is manipulated around a defined range of travel (e.g., defined by the opening 4130 and the connector 4139 disposed therein).In some aspects, the notches 4132 can correspond to increments of the setting (eg, each notch represents 5 degrees, 10 degrees, or 15 degrees of rotation, etc.).

[0107] Once the clamp 4102 is secured to the foot 4200, one or both of the actuators 4124, 4136 can be manipulated (e.g., actuated) to releasably couple the actuator 4136 to the first metatarsal 4202 via the first stabilizing wire 4146, and at least the second stabilizing wire 4148 (if not multiple second stabilizing wires) to releasably couple the second portion 4106 to the second metatarsal 4204, to position / reposition the first and / or second metatarsals 4202, 4204 in one or more anatomical planes. For example, the actuator 4124 can be manipulated to translate the first portion 4104 substantially laterally along a longitudinal axis of the actuator 4124 (e.g., toward the second portion 4106 as shown by the double arrow in FIG. 48) (e.g., rotate as in the knob / setscrew configuration shown in the exemplary embodiment of FIGS. 39-53). Thus, with the first portion 4104 coupled to the first metatarsal 4202 via the actuator 4136 and the first stabilization wire 4146, such movement of the first portion 4104 (substantially lateral movement along the longitudinal axis of the actuator 4124 toward the second portion 4106) manipulates the first metatarsal 4202 such that the IM angle between the first metatarsal 4202 and the second metatarsal 4204 (e.g., the angle formed by the longitudinal axes of the first metatarsal 4202 and the second metatarsal 4204) is reduced. When such a force is applied, the clamp 4102 and its various components remain releasably coupled to and / or otherwise in contact with one or more portions of the first metatarsal 4202 and the second metatarsal 4204.

[0108] As previously discussed, the first metatarsal 4202 can be further positioned / repositioned (after the second portion 4106 is coupled to the second metatarsal 4204) by manipulation of the actuator 4136. Manipulation of the actuator 4136 (via the first portion 4138) within a range of movement defined by the aperture 4130 and the connector 4139 disposed therein (e.g., from a first position 4150 in FIG. 47 to a second position 4152 in FIG. 48, as shown by the arrow in FIG. 48) applies a rotational force to the first metatarsal 4202 in the frontal plane (e.g., to address a rotational deformity) to rotate / derotate the first metatarsal. While such a force is applied to the first metatarsal via the actuator 4136, the first portion 4104, second portion 4106 and other components of the clamp 4102 remain stationary as a function of the releasable coupling with the first metatarsal 4202 and second metatarsal 4204 (e.g., the releasable coupling between the actuator 4136 and the first metatarsal 4202 via the second stabilizing wire 4148 releasably coupling the second portion 4106 to the second metatarsal 4202, the retaining feature 4114 in contact with at least one surface of the second metatarsal 4202, the first stabilizing wire 4146, etc.).

[0109] 50-51, as shown, a surgical guide 4300 is coupled to a proximal portion of the first metatarsal 4202 adjacent the lapidus joint 4208. In some aspects, the surgical guide 4300 can be provided in a kit or other system along with the system 4100 and / or one or more implants and / or fixation components (as well as various other instruments / components). Additionally, in some aspects, the surgical guide 4300 can be configured to facilitate one or more incisions made on the first metatarsal 4202. The surgical guide 4300 includes a handle 4302 extending laterally from a cut guide 4304 of the surgical guide 4300. As shown, an end of the handle 4302 includes a haptic finish configured to facilitate gripping the handle 4302 of the surgical guide 4300. The cut guide 4304 includes a slot 4312 located in a central portion of the cut guide 4304. 50-51 show a slot 4312 having a substantially elongated geometry configured to receive one or more cutting instruments (e.g., reciprocating saws, etc.). In some aspects, the slot 4312 may have alternative geometries and / or dimensions, e.g., the slot 4312 may have length and / or width dimensions that are greater or less than the length and / or width dimensions of the slot shown. The cutting guide 4304 further includes a protrusion 4306, as shown, that extends laterally from a side of the cutting guide 4304 opposite the side from which the handle 4302 extends. The protrusion 4306 includes a bore 4308 that is substantially centered within a top surface of the protrusion 4306, the bore 4308 extending through the protrusion 4306 from the top surface to its bottom surface, thereby establishing fluid communication between the top and bottom surfaces of the protrusion 4306. The bore 4308 receives a stabilizing wire 4310 (which may be the same and / or similar to the first and / or second stabilizing wires 4146, 4148) therethrough, as shown, such that the stabilizing wire 4310 can releasably couple the surgical guide 4300 to the proximal portion of the first metatarsal 4202.In some aspects, for example, in the exemplary surgical guide 4300 shown in FIG. 51 , the protrusion 4306 can include a plurality of bores 4308, for example, a pair of bores 4308 as shown. In some aspects, one or more stabilizing wires 4310 can be received through the bores 4308 to releasably couple the surgical guide 4300 to the first metatarsal 4202 at one or more locations. Additionally, in some aspects, the surgical guide 4300 can include a protrusion (e.g., a paddle, etc., not shown in FIGS. 50-51 ) configured to be inserted into the joint space of the Lapidus joint 4208 (e.g., between the first metatarsal 4202 and the medial cuneiform 4206).

[0110] 52, as shown, a surgical guide 4400 is coupled to a distal portion of the medial cuneiform bone 4206 and a proximal portion of the first metatarsal bone adjacent the lapidus joint 4208. In some aspects, the surgical guide 4400 can be provided in a kit or other system along with the clamp 4100 and / or one or more implants and / or fixation components (as well as various other instruments / components). Furthermore, in some aspects, the surgical guide 4400 can be configured to facilitate one or more incisions made in the medial cuneiform bone 4206. The surgical guide 4400 includes a body 4401 pivotally coupled to a cutting guide 4402 at a coupling 4403. The cutting guide 4402 includes a slot 4405 located in a central portion of the cutting guide 4402. As shown in FIG. 52, the slot 4405 has a substantially elongated geometric shape configured to receive one or more cutting instruments (e.g., a reciprocating saw, etc.). In some aspects, the slot 4405 may have alternative geometric shapes and / or dimensions, for example, the slot 405 may have length and / or width dimensions that are greater or less than the length and / or width dimensions of the slot shown. As shown, the coupling 4403 includes a protrusion of a body 4401 having a substantially cylindrical shape that is received by a bore of a cutting guide 4402 having a complementary cylindrical shape. The coupling 4403 thereby allows for pivotal movement of the cutting guide 4402 relative to the body 4401. The body 4401 is shown to include a base 4408, which includes a pair of bores 4410. The bores 4410 are configured to receive one or more stabilizing wires (each of which may be the same and / or similar to those previously shown and described herein) to facilitate releasable coupling of the surgical guide 4400 to the medial cuneiform bone 4206. The cutting guide 4402 includes cross members 4404 extending on either side from a distal-most portion of the cutting guide 4402. The cross member 4404 includes a pair of bores 4406 located in a distal portion of each segment of the cross member 4404, each of the bores 4406 configured to receive a stabilization wire (such as those shown and described herein).The cut guide 4402 can be pivoted relative to the body 4401 such that one of the bores 4406 is positioned adjacent the medial cuneiform 4206 and the other of the bores is positioned adjacent the first metatarsal 4202. Thus, the cross member 4404 and its bore 4406 are configured to facilitate coupling with the first metatarsal 4202 and / or the medial cuneiform 4206 after being pivoted (by the cut guide 4402) relative to the body 4401. The body further includes a protrusion 4412 configured to be positioned within the joint space of the Lapidus joint 4208 (e.g., between a distal portion of the medial cuneiform 4206 and a proximal portion of the first metatarsal 4202).

[0111] Referring to FIG. 54, a fixation system 4500 on a foot 4200 is shown. The fixation system 4500 shown in FIG. 54 is by no means limited thereto and may include one or more other fixation system elements including, for example, an intramedullary nail, one or more plates and / or fasteners, drills, etc. The system 4500, partially shown in FIG. 45, includes a pair of wires 4502 including a first wire 4504 and a second wire 4506. As shown, the first wire 4504 is inserted into the dorsal surface of the proximal portion of the first metatarsal 4202 from an anterior-to-posterior direction. In some aspects, the first wire 4504 can cross the Lapidus joint 4208 (or where the Lapidus joint 4208 was previously located, if the joint is already prepared for fixation) and extend into the medial cuneiform 4206. The second wire 4506 is shown inserted in a medial-to-lateral direction into the medial surface of the first metatarsal 4202, exiting the lateral surface of the first metatarsal 4202, and into the medial surface of the second metatarsal 4204. In some aspects, the second wire 4506 may extend out the lateral side of the second metatarsal 4204. The pair of wires 4502 is configured to provide temporary fixation and / or stability and / or immobility of the first metatarsal 4202, the second metatarsal 4204, the medial cuneiform 4206, and / or other anatomical structures adjacent the Lapidus joint 4208. In some aspects, the pair of wires 4502 can be placed before a fixation element (e.g., an intramedullary nail, one or more plates and supplemental fasteners, etc.) is implanted.

[0112] 55-63, an exemplary embodiment of a system 4600 is shown for implementation when performing a procedure on one or more anatomical structures of the foot (e.g., a Lapidus joint procedure, such as an arthrodesis or other similar fixation procedure). The system 4600 may include one or more components and / or features thereof the same as and / or similar to the system 4100 previously shown and described. Similarly, the system 4600 and its components may interface (e.g., contact, couple, etc.) with the foot 4200 and its components (e.g., the first metatarsal 4202, the second metatarsal 4206, the medial cuneiform 4206, the Lapidus joint 4208, etc.) in a manner the same as and / or similar to that shown with reference to the system 4100. Additionally, the system 4600 may be implemented utilizing a process for performing the same and / or similar surgical method as the system 4100, such as the surgical method shown and described herein.

[0113] As shown and described herein with reference to Figs. 46-46, the system 4600 includes the clamp 4602 and may further include one or more additional components, such as one or more surgical guides as shown and described herein. Additionally, the system 4600 may be implemented by performing one or more steps of the method shown and described with reference to Fig. 66. Additionally, it is understood that the system 4600 may include one or more components (e.g., dissection instruments, saws, scalpels, forceps, retractors, etc.) in addition to those shown and described herein. The method shown and described with reference to Fig. 66 may incorporate said additional components.

[0114] 55-63 illustrate an exemplary instrument shown as clamp 4602, which is a device for determining, aligning / realigning, correcting, positioning / repositioning, rotating / derotating, or otherwise manipulating one or more anatomical structures of the foot relative to other anatomical structures of the foot in accordance with the present disclosure. Clamp 4602 is configured to releasably couple to foot structures including a first metatarsal (shown as reference numeral 4202) and a second metatarsal (shown as reference numeral 4204) the same and / or similar to those shown and described in FIGS. 47-53, and can manipulate a Lapidus joint (shown as reference numeral 4208) configured between the first metatarsal 4204 and the medial cuneiform (shown as reference numeral 4206). In some aspects, the clamp 4102 may be mounted on a distal portion of the first metatarsal 4202 and the second metatarsal 4204, but may also be mounted elsewhere around the first metatarsal 4202 and the second metatarsal 4204. The clamp (and its components) 4602 is configured to facilitate correction of an IM angle formed between a first longitudinal extension axis of the first metatarsal 4202 and a second longitudinal extension axis of the second metatarsal 4204. Additionally, the clamp 4602 is configured to facilitate derotation of the first metatarsal 4202 relative to the second metatarsal 4204 (e.g., a rotation opposite to the rotation that caused the hallux valgus or other deformity). Correction of the IM angle and / or derotation of the first metatarsal 4202 relative to the second metatarsal 4204 can be performed by a physician in a procedure to address a deformity at or near the lapidus joint (e.g., hallux valgus, lapidus joint arthrodesis, etc.).

[0115] As shown, the clamp 4602 includes a first portion 4604 and a second portion 4606, where the first portion 4604 is releasably coupled to the second portion 4606 by / at a coupling 4608. In some aspects, the coupling 4608 may include a coupling mechanism (e.g., a thread and a complementary bore, etc.). A first component of the coupling is coupled to or integral with the first portion 4604, and a second component complementary to the first component is coupled to or integral with the second portion 4606. Furthermore, in some aspects, the coupling 4608 may include a portion of the coupling mechanism, where at least a portion of the coupling mechanism is configured to extend at least partially within the second portion 4606. Such a portion of the coupling mechanism may be coupled to or integral with the first portion 4604, and may further extend at least partially within an opening in the second portion 4606. In some aspects, at least a portion of the coupling may include incremental markers (e.g., indicators, measurement markers, etc.) that indicate expansion of the clamp 4602. The coupling 4608 (and any components thereof) may also facilitate movement of the first portion 4604 relative to the second portion 4606 or facilitate movement of the second portion 4606 relative to the first portion 4604. In some aspects, an actuator 4624 (e.g., a knob, etc.) disposed substantially along a longitudinal axis of the second portion 4606 may be configured to releasably couple with a portion of the second portion 4606 of the clamp 4602. For example, the actuator 4624 may include a protrusion (e.g., a male component with threads, set screw, etc.) that extends longitudinally into and through a bore disposed in the second portion 4606 of the clamp to facilitate releasable coupling of the coupling 4608 with the first portion of the clamp 4604 (e.g., complementary threads, etc.). In some aspects, the bore may include a coupling mechanism therein (e.g., a screw thread, etc.) that is configured to releasably mate with a complementary portion of the actuator 4624 (e.g., the protrusion having a coupling mechanism such as a screw thread).Thus, manipulation of the actuator 4624 via the textured surface 4626 (e.g., to facilitate gripping, rotation, manipulation, etc.) can cause the second portion 4606 to translate toward or away from the first portion 4604 to expand the clamp 4602. In some aspects, the translation can be along a shared (e.g., common) longitudinal axis by one or more of the actuator 4624, the protrusion from the actuator 4624, the bore of the second portion 4606, and any complementary coupling features of the first portion 4604. Additionally, the first portion 4604 and the second portion 4606 can be coupled such that one or both portions are operable about a longitudinal axis (e.g., a shared / common axis).

[0116] As shown, the second portion 4606 of the clamp 4602 includes a pair of projections 4618 extending laterally from the second portion 4606. As shown in FIGS. 55-63, the pair of projections 4618 are disposed along the second portion 4606 such that they are spaced apart from the actuator 4624. This causes the projections 4618 to be substantially adjacent to the coupling 4608 (rather than an alternative location as shown with reference to the system 4100). In some aspects, the actuator 4624 may include at least a portion of a coupling feature configured to be complementary to a coupling feature of the coupling 4608. For example, the actuator 4624 may include an extension having threads configured to be received within at least a portion of the coupling 4608. In some aspects, the extension of the actuator 4624 may be configured to releasably couple the second portion 4606 to the first portion 4604 via the coupling 4608. Although the projections 4618 are shown as being substantially hemispherical, in some embodiments of the clamp 4602, the projections 4618 may include alternative geometric shapes. As shown, each projection includes a bore 4620 having a substantially cylindrical shape and extending from a top surface to a bottom surface of the second portion 4606 such that fluid communication is established therebetween. The bore 4620 may be configured to receive one or more common surgical instruments, such as stabilization wires, K-wires, olive wires, and / or other stabilization elements, to releasably couple the second portion 4606 with the second metatarsal 4204. As shown in FIGS. 47-53, the stabilization wire may be positioned such that the wire is received in the bore 4620, with the wire being inserted substantially into the dorsal portion of the second metatarsal 4204 (similar to that shown in FIGS. 47-53, being positioned closer to the proximal end of the second metatarsal 4204 than the distal end). In some embodiments, a physician may choose to place a stabilization wire in one / any one of the bores 4620 rather than placing a stabilization wire in each of the bores 4620.When releasably coupled to the second metatarsal 4204 via a stabilization wire received through the bore 4620, the second portion 4606 of the clamp 4602 can be configured to be in a rest position when the actuator 4624 is manipulated to translate the first portion 4604 toward the second portion 4606 (e.g., with the second portion 4606 stationary secured to the second metatarsal 4204, the actuator 4624 is manipulated to translate the first portion 4604 toward the second portion 4606 and the second metatarsal 4204). In some embodiments, the bores 4620 may have different sizes (e.g., both large, both small, or one larger / one smaller) and / or geometric shapes (e.g., rectangular, triangular, etc.) to accommodate various stabilization element geometries. While each of the pair of protrusions 4618 is shown having an equal size, in some embodiments, the second portion 4606 of the clamp 4602 can include one, two, or more protrusions, such as the same or similar protrusions 4618 (having equal or unequal sizes) variously disposed along the second portion 4606. Further, in some embodiments, one or more of the protrusions 4618 can include zero, one, two, three, or more bores variously disposed about the circumference of the protrusions 4618. As shown, each of the bores 4620 is disposed substantially equidistant from the outer edge of the protrusions 4618, although in some embodiments of the clamp 4602, the bores 4620 can be staggered.

[0117] As shown, the second portion 4606 of the clamp 4602 includes an extension 4610 configured on an opposite side of the second portion 4606 from the coupling 4608, and as shown in FIGS. 55-63, the extension 4610 extends from the second portion 4606 at a substantially perpendicular angle from the second portion 4606 from a point adjacent the actuator 4624. As shown, the extension 4610 has a substantially rectangular cross-sectional shape, but may have alternative shapes in some embodiments of the system 4600. The extension 4610 includes a retention feature 4614, which is shown in FIGS. 47-53 as a pair of protrusions disposed at a distal end of the extension 4610 (e.g., opposite the second portion 4606 adjacent the actuator 4624). The retention feature 4614 defines a cavity 4616 disposed substantially between the pair of protrusions of the retention feature 4614. The cavity 4616 of the clamp 4602 can extend further into the extension (e.g., substantially in a direction toward the protrusion 4618) than the extension 4116 of the clamp 4102. As shown, the retention feature 4614 is integral with the extension 4610 and has a curvature that is substantially toward the first portion 4604 of the clamp 4602 (e.g., adjacent a tangent to that curvature that is substantially perpendicular to the second portion 4606), with a distal-most portion of the retention feature 4614 facing substantially toward the first portion 4604 of the clamp 4602. The cavity 4616 is shown to have a substantially semi-elliptical geometry, with the semi-elliptical geometry disposed at a proximal-most portion of the cavity 4616. However, in some aspects, the cavity 4616 (and retention feature 4614) may have alternative thickness / width, length, depth, curvature, and other geometric characteristics.

[0118] The extension 4610 and the retaining feature 4614 are configured to at least partially interface (e.g., engage, contact, etc.) with a plateau of the second metatarsal 4204 located substantially on the lateral side of the second metatarsal 4604. The retaining feature 4614, including its distal-most portion, can be configured to contact a substantially lower portion of the plateau on the lateral side of the second metatarsal 4204. The curvature of the distal-most portion of the retaining feature 4614 is configured to at least partially surround the second metatarsal 4204 such that the retaining feature 4614 contacts at least a portion of the plantar surface of the second metatarsal 4204 (thus engaging multiple surfaces of the second metatarsal 4204). Thus, the curvature of the retention feature 4614 adapts to the geometry of the second metatarsal 4204 so as to maximize engagement of the retention feature 4614 with the second metatarsal 4204 when a force is applied to the second metatarsal 4204 via the retention feature 4614 (e.g., a force is applied in a medial and / or superior direction to the lateral and / or plantar surface of the second metatarsal 4204). Thus, the retaining feature 4614 maximizes engagement of the extension 4610 of the second portion 4606 of the clamp 4602 with the second metatarsal 4204, reducing / preventing loss of contact / engagement between the clamp 4602 and the second metatarsal 4204 as more force is applied to the second metatarsal 4204 (e.g., manipulation of the actuator 4624 to translate one or both of the first portion 4604 and the second portion 4606 toward or away from each other while the extension 4610 and / or the retaining feature 4614 are in contact with the second metatarsal 4204). In some aspects, the cavity 4616 can be configured to receive (e.g., allow passage of) one or more stabilization wires.

[0119] As shown, the first portion 4604 of the clamp 4602 has a substantially curved geometric shape (e.g., convex), with the curvature of the first portion 4604 pointing substantially toward the second portion 4606. The first portion 4604 includes an opening 4630 disposed substantially at the distal portion 4628 (e.g., distal half) of the first portion 4604. As shown in FIGS. 55-63, the opening 4630 has a rounded and elongated geometric shape (e.g., elliptical, oval, etc.) having the same curvature as the first portion 4604. The opening 4630 is disposed within an inner recess 4633 on the concave surface and an outer recess 4634 on the convex surface of the first portion 4604. The inner recess 4633 and the outer recess 4634 are shown to have similar depth, length, and width dimensions, with the inner recess 4633 and the outer recess 4634 having a greater length and width than an opening 4630 of the same / similar geometry. Further, the inner recess 4633 and the outer recess 4634 are disposed at approximately the same location on each surface of the distal portion 4628 of the first portion 4604 .

[0120] As shown, the first portion 4604 further includes an actuator 4636 having a first portion 4638 and a second portion 4640. The first portion 4638 and the second portion 4640 are separated by a connector 4639. As shown, the connector 4139 has a cross-sectional shape that is substantially smaller than the cross-sectional shape of the first portion 4638 or the second portion 4640. In some aspects, the connector 4639 may include an extension having at least a portion of a coupling mechanism (e.g., a thread) configured complementary to an opening disposed substantially along the longitudinal axis of the first portion 4638. Such a coupling mechanism may thus facilitate a releasable coupling between the first portion 4638 and the second portion 4640 of the actuator 4636. As shown in FIGS. 55-63, the connector 4639 has a substantially cylindrical geometry with a diameter / lateral dimension slightly smaller than the diameter / lateral dimension of the opening 4630. 55-63, the first portion 4638 is shown to have a substantially cylindrical shape with a diameter slightly less than the width of the outer recess 4634. The second portion 4640 is also shown to have a lateral dimension slightly less than the width of the inner recess 4633. As shown in FIGS. 55-63, the actuator 4636 is positioned such that at least a portion of the connector 4639 is disposed within the opening 4630. Similarly, a distal-most portion of the first portion 4640 is disposed within the outer recess 4634 and a distal-most portion of the second portion 4640 is disposed within the inner recess 4633. Thus, the range of movement of the actuator 4636 is defined by the dimensions of the opening 4630 (in some embodiments, as well as the inner recess 4633 and the outer recess 4634). The actuator 4636 is manipulated through a defined range of motion along the curvature of the first portion 4604, the boundaries of which are defined by the opening 4630 (in some embodiments, as well as the inner recess 4633 and / or the outer recess 4634). The actuator 4636 also includes a texture 4642 on an outer surface of the first portion 4638 of the actuator 4636, which texture 4642 is configured to facilitate grasping and / or manipulation of the actuator 4636 (e.g., rotating it through the range of motion, etc.).

[0121] The actuator 4636 includes a bore 4644 that extends from the first portion 4638, through the connector 4639, and along the longitudinal axis of the actuator 4636 to the second portion 4640. This establishes fluid communication through the length of the actuator 4636. As shown in FIGS. 55-63, the bore 4644 has a substantially cylindrical geometry configured to receive a stabilization wire (e.g., a K-wire, an olive wire, etc.) passing through the bore 4644 of the actuator 4636. A first stabilization wire, the same as or similar to the stabilization wire 4148 previously shown and described, can be received by the bore 4644 and inserted (e.g., releasably coupled) into the first metatarsal 4202 (as shown, a substantially medial portion of the first metatarsal 4202). Thus, when the first stabilization wire is positioned within the first metatarsal 4202, the actuator 4636 is releasably coupled to the first metatarsal 4202. By manipulating the actuator 4636 within a range of movement defined by movement of the connector 4639 within the aperture 4630, the first metatarsal 4202 is moved accordingly.

[0122] 64-65, an exemplary embodiment of a surgical guide 4700 is shown. In some aspects, the surgical guide 4700 can be provided as part of a kit or other system along with the system 4600 and / or one or more implants and / or fixation components (as well as various other instruments / components). Additionally, in some aspects, the surgical guide 4700 can be configured to facilitate one or more incisions made to the first metatarsal bone 4202 (and can be positioned and / or coupled in the same and / or similar manner as shown and described with reference to the cut guide 4300). The surgical guide 4700 includes a handle 4702 extending laterally from the cut guide 4704 of the surgical guide 4700. As shown, an end of the handle 4702 includes a haptic finish configured to facilitate gripping the handle 4702 of the surgical guide 4700. The cut guide 4704 includes a slot 4712 located in a central portion of the cut guide 4702. As shown in FIGS. 64-65, the slot 4712 has a substantially elongated geometry configured to receive one or more cutting instruments (e.g., a reciprocating saw, etc.). In some aspects, the slot 4712 may have alternative geometries and / or dimensions, for example, the slot 4712 may have length and / or width dimensions that are greater or less than the length and / or width dimensions of the illustrated slot. The cutting guide 4704 is further shown to include an extension 4706 extending laterally from a side of the cutting guide 4704 opposite the side from which the handle 4702 extends. The extension 4706 includes a bore 4708 that is substantially centrally located on a top surface of the extension 4706, the bore 4708 extending from the top surface of the extension 4706 to its bottom surface, thereby establishing fluid communication between the top and bottom surfaces of the extension 4706. The bore 4708 is configured to receive a stabilization wire (which may be the same and / or similar to the stabilization wires previously illustrated and described herein) therethrough such that the stabilization wire can be releasably coupled to the proximal portion of the first metatarsal 4202.In some aspects, the surgical guide 4700 and its extension 4706 can include a number of bores 4708, such as a pair of bores 4708. In some aspects, one or more stabilization wires can be received through the one or more bores 4708 to releasably couple the surgical guide 4700 to the first metatarsal 4202 at one or more locations. Additionally, in some aspects, the surgical guide 4700 includes a protrusion 4714 (e.g., a paddle, etc.) configured to be inserted into the joint space of the Lapidus joint 4208 (e.g., between the first metatarsal 4202 and the medial cuneiform bone 4206).

[0123] Referring to FIG. 66, a process or method 6000 for performing a Lapidus joint treatment is shown, according to an exemplary embodiment. The process 6000 and its steps shown in FIG. 66 can be performed by implementing one or more of the components shown and described herein with reference to FIG. 39 to FIG. 65. It should also be noted that one or more steps of the process 6000 can be performed in a different order (e.g., out of order), repeated, skipped, or otherwise modified. It should also be noted that the steps of the process 6000 are not limiting, i.e., additional steps can be added to the process 6000 when performing a Lapidus joint treatment. The steps of the process 6000 described herein may include references to one or more components of the systems 4100, 4600 previously shown and described herein. It should also be noted that in some aspects, one or more steps of process 6000 may include components of one of systems 4100, 4600 (e.g., when a component is included as "system 4100, 4600," it is not necessary to implement components of both systems 4100 and 4600 or both systems to complete the above step).

[0124] According to some aspects, as shown, process 6000 includes step 6002, which includes coupling a portion of the device to the second metatarsal using at least one stabilization wire. In some aspects, step 6002 may include implementing one or more stabilization wires such as those previously shown and described herein. Step 6002 may correspond to coupling the second portion 4106, 4606 to the second metatarsal 4204, as previously shown and described herein.

[0125] According to some aspects, as shown, the process 6000 includes step 6004, which is coupling a portion of the device to the first metatarsal. In some aspects, step 6004 may include implementing one or more stabilizing wires as previously shown and described herein. Step 6004 can include coupling the first portion 4104, 4604 to the first metatarsal 4202 as previously shown and described herein.

[0126] According to some aspects, as shown, the process 6000 includes a step 6006, which is coupling a surgical guide adjacent the Lapidus joint. In some aspects, the step 6006 may include coupling a surgical guide that is the same as or similar to the surgical guide 4300 previously shown and described. The surgical guide of step 6006 may be coupled to at least the first metatarsal 4202 at a substantially proximal portion thereof using one or more stabilizing wires, as previously described herein.

[0127] According to some aspects, as shown, the process 6000 includes step 6008, which prepares a proximal portion of the first metatarsal. Step 6008 may include implementing one or more cutting instruments (and other possible instruments) to prepare the proximal portion of the first metatarsal 4202. When performing step 6008, one or more of the cutting instruments described above may be inserted into or through one or more slots 4312, as shown with reference to the surgical guide 4300.

[0128] According to some aspects, as shown, the process 6000 includes a step 6010, which operates an actuator to decrease the distance between the first and second portions of the device, thereby decreasing the distance between the first and second metatarsals. In some aspects, the actuator operated in step 6010 may be the actuator 4124, 4624 shown and described with reference to FIGS. 39-54, where the actuator 4124, 4624 may be actuated (e.g., rotated) to decrease the distance between the first and second portions 4104, 4604 and 4106, 4606 of the clamps 4102, 4602. The distance between the first and second metatarsals may be decreased by decreasing the distance between the first and second portions 4104, 4604 and 4106, 4606 coupled to the first and second metatarsals 4202, 4204.

[0129] According to some aspects, as shown, the process 6000 includes step 6012, which manipulates an actuator to rotate the first metatarsal. In some aspects, the actuator manipulated in step 6012 may be the actuator 4136, 4636 shown and described with reference to FIGS. 39-65, and the actuator 4136, 4636 may be translated (e.g., manipulated) around / through a prescribed range of motion. Such manipulation of the actuator 4136, 4636 may rotate the first metatarsal 4202 in a substantially counterclockwise direction when viewed from the front (when applied to the patient's right foot).

[0130] According to some aspects, as shown, the process 6000 includes step 6014, which couples a surgical guide adjacent the Lapidus joint. In some aspects, the surgical guide of step 6014 may be the same as and / or similar to the surgical guides 4400, 4700 shown and described with reference to FIGS. 52 and 64-65. Step 6014 may further include manipulating one or more components of the surgical guides 4400, 4700 (e.g., steerable, pivotable, etc., as previously described), followed by coupling one or more portions / components of the surgical guides 44400, 4700 to a distal portion of the medial cuneiform bone 4206 using one or more stabilization wires. In some aspects, step 6014 can include positioning and / or manipulating the surgical guide 4400, 4700 to prepare a distal portion of the medial cuneiform bone 4206 having a surface that is substantially parallel (e.g., a parallel plane) to a surface of the proximal face of the first metatarsal bone by inserting one or more incision instruments into / through the incision slots 4412, 4712.

[0131] According to some aspects, as shown, the process 6000 includes a step 6016, which prepares a distal portion of the medial cuneiform bone. In some aspects, the step 6016 may include preparing a distal-most surface of the medial cuneiform bone 4206 to be parallel with a corresponding proximal surface of the first metatarsal bone 4202 (e.g., to promote maximum surface area contact between the distal surface of the medial cuneiform bone 4206 and the proximal surface of the first metatarsal bone 4202). The step 6016 may include implementing one or more dissection instruments (and other possible instruments) to prepare the distal portion of the medial cuneiform bone 4206. When performing the step 6016, one or more of the dissection instruments described above may be inserted into / through one or more slots 4412, 4712, as shown with reference to the surgical guide 44400.

[0132] According to some aspects, as shown, the process 6000 includes a step 6018, which applies a fixation device across the Lapidus joint. In some aspects, the fixation device of step 6018 can include an intramedullary nail and / or one or more plating components (including but not limited to those incorporated by reference herein). The fixation device can be coupled to the first metatarsal 4202, the medial cuneiform 4206, and in some aspects can also be coupled to one or more musculoskeletal structures near the Lapidus joint 4208 using one or more fastening means (e.g., screws, fasteners, etc.).

[0133] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present invention. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. Additionally, the terms "comprise" (and any form of "comprise," including, for example, "comprises," "comprising," etc.), "have" (and any form of "have," including, for example, "has," "having," etc.), "include" (and any form of "include," including, for example, "includes," "including," etc.), and "contain" (and any form of "contain," including, for example, "contains," "containing," etc.) are open-ended conjunctive verbs. Thus, a method or apparatus that "comprises," "has," "includes," or "contains" one or more steps or elements includes those one or more steps or elements, but is not limited to including only those one or more steps or elements. Similarly. A method or apparatus that "comprises," "has," "includes," or "contains" one or more features includes those one or more features, but is not limited to including only those one or more features. Furthermore, an apparatus or structure that is configured in a certain way may be configured in at least that way, but may also be configured in ways not recited.

[0134] The present invention has been described with reference to preferred embodiments. It is to be understood that the architectural and operational embodiments described herein are examples of several possible configurations for providing the same general features, characteristics, and general system operation. Modifications and alterations will occur to others upon reading and understanding the preceding detailed description. It is intended that the present invention be construed as including all such modifications and alterations.

Claims

1. A clamp comprising an actuating portion and an engaging portion coupled to the actuating portion via a coupling portion, The engagement portion is a first arm including a first engagement element disposed at a distal end of the first arm; a second arm including a second engagement element disposed at a distal end of the second arm; Equipped with Clamp.

2. the first engagement element is different from the second engagement element; The clamp of claim 1 .

3. the second engagement element being integral with the second arm; The clamp of claim 2.

4. the second engagement element has a vertically tapered shape; The clamp of claim 3.

5. the second engagement element includes a flat portion disposed on an inner surface thereof, the flat portion including a textured surface; The clamp of claim 4.

6. the textured surface is configured to contact at least a portion of the first metatarsal such that the second engagement element maintains contact with the first metatarsal. The clamp of claim 5.

7. the first arm includes an opening located at a distal end, the opening configured to rotatably couple with the first engagement element; The clamp of claim 1 .

8. The first engagement element includes a retainer and an actuator. The clamp of claim 7.

9. the retention portion includes a post; At least a portion of the post is configured to be received in the aperture of the first arm to facilitate a rotatable and releasable coupling between the first engagement element and the first arm. The clamp of claim 8.

10. the actuator includes a central opening configured to receive at least a portion of the post such that the actuator is positioned below the opening in the first arm and above the retainer. The clamp of claim 8.

11. The retaining portion further includes a first retaining element and a second retaining element extending from the post. The clamp of claim 9.

12. The distance between the first and second retaining elements is adjusted by manipulating the actuator around a screw disposed on a surface of the retaining portion. The clamp of claim 11.

13. each of the first and second retaining elements includes a textured surface configured to interface with a second metatarsal bone; The clamp of claim 11.

14. the retainer is rotatably coupled to the opening of the first arm such that the retainer has a 360 degree range of motion. The clamp of claim 8.

15. The first arm has a different shape than the second arm. The clamp of claim 1 .

16. the first engagement element has a different depth than the second engagement element; The clamp of claim 1 .

17. 1. A surgical system comprising a clamp and a fixation device, The clamp is An actuation portion; the engagement portion coupled to the actuation portion via a coupling portion disposed between the engagement portion and the actuation portion; Equipped with The engagement portion includes a first arm and a second arm, the first arm includes a first engagement element disposed at a distal end of the first arm, the first engagement element comprising an actuator rotatably and releasably coupled to the first arm and configured to adjust a distance between the first retention element and the second retention element such that each of the first retention element and the second retention element engages at least a portion of a second bone; the second arm includes a second engagement element disposed at a distal end of the second arm, the second engagement element being an integral element of the second arm and configured to contact a surface of a first bone. Surgical system.

18. Operation of the actuator increases or decreases the distance between the first engagement element and the second engagement element. The surgical system of claim 17.

19. the first engagement element comprises a retention portion including a post and threads; the post is configured to releasably couple with the first arm and the thread is configured to releasably couple with the actuator. The surgical system of claim 17.

20. 1. A surgical system comprising a clamp, The clamp is a first portion including a first actuator configured to interface with a first metatarsal of the patient, the first actuator having a range of motion defined by an aperture; a second portion including an extension having a retention feature configured to interface with a second metatarsal of the patient; Including, the second portion is releasably coupled to the first portion, the first portion and the second portion being translatable relative to one another via a second actuator; The surgical system further comprises a plurality of stabilization wires configured to be received by at least one of the first and second portions. Surgical system.

21. the first actuator includes a first bore disposed about a longitudinal axis of the actuator; The surgical system of claim 20.

22. the first bore is configured to receive a stabilization wire within and through the bore such that one of the plurality of stabilization wires releasably couples the first actuator with the first metatarsal. The surgical system of claim 21.

23. Manipulation of the first actuator within the aperture applies a rotational force to the first metatarsal via at least one of the plurality of stabilization wires to manipulate the first metatarsal from a first position to a second position. The surgical system of claim 22.

24. and manipulating the first actuator within the aperture moves at least one of the plurality of stabilization wires from a first position forming a first angle with the transverse plane to a second position forming a second angle with the transverse plane, the first angle being different from the second angle. The surgical system of claim 23.

25. the first angle is greater than the second angle; The surgical system of claim 24.

26. the retention mechanism is disposed at a distal end of the extension and includes a pair of curved protrusions; A recess is defined between the pair of protrusions. The surgical system of claim 20.

27. the protrusion is curved toward the first portion of the clamp; 27. The surgical system of claim 26.

28. the second actuator is disposed at an end of the second portion opposite the first portion; The surgical system of claim 20.

29. the second portion includes a bore extending through the second portion along a longitudinal axis thereof; The surgical system of claim 20.

30. the second actuator includes a protrusion having a first coupling mechanism, the protrusion configured to be received by and extend through the bore; the protrusion is configured to releasably couple with the second portion through the bore. The surgical system of claim 20.

31. the first portion includes a recess including a second coupling mechanism, the recess configured to receive and releasably couple a portion of the protrusion of the second actuator.

30. The surgical system of claim 28.

32. the recess of the first portion and the bore of the second portion share a common axis with the protrusion of the second actuator when both are releasably coupled to the protrusion. The surgical system of claim 31.

33. Operation of the second actuator translates the first portion relative to the second portion about the shared axis. The surgical system of claim 20.

34. each of the first actuator and the second actuator includes a texture disposed on one or more exterior surfaces thereof; The surgical system of claim 20.

35. the second portion includes one or more protrusions; each of the protrusions includes an opening configured to receive one of the stabilization wires; The surgical system of claim 30.

36. 1. A surgical clamp comprising a first portion and a second portion, The first portion is having a substantially curved shape; a recess located at a proximal end of the first portion; an elongated opening located at a distal end of the first portion; a first actuator at least partially disposed within the elongated aperture such that the elongated aperture defines a range of motion for the first actuator, the first actuator including a bore extending therethrough along a longitudinal axis thereof and configured to receive a stabilization wire; Including, The second portion is an extension including a pair of protrusions at a distal end of the second portion; a bore extending along a longitudinal axis of the second portion; a second actuator including a coupling mechanism configured to be received through and releasably coupled to the bore, the coupling mechanism configured to be received in and releasably coupled to the recess such that operation of the second actuator causes the first and second portions to translate about a longitudinal axis of the second portion; and Including, Surgical clamps.

37. the first portion includes at least one bore configured to receive a stabilization wire; 37. The surgical clamp of claim 36.

38. the second portion includes at least an opening configured to receive a stabilization wire; 37. The surgical clamp of claim 36.