Implants, systems, instruments and methods of using the same

Abstract

Implants, devices, instruments, systems and methods for replacing an articulation surface in a joint, for example, unicompartmental knee implants. A femoral resection assembly including a femoral cut guide and a spacer coupled to an inferior surface of the femoral cut guide. A fin punch for receipt within the femoral cut guide. A tibial resection guide and keel cutter for preparing a patient's tibia for insertion of a tibial implant. A tibial insertion system including a handle, an impaction inserter coupled to an inferior end of the handle, a tibial implant coupled to an inferior end of the impaction inserter, and an implant packaging assembly that receives the impaction inserter and tibial implant. Methods for implanting the unicompartmental knee implants are also disclosed.

Description

Docket No. : 6323.003A WOIMPLANTS, SYSTEMS, INSTRUMENTS AND METHODS OF USING THE SAMECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 63 / 551,870, filed February 9, 2024 and entitled Implants, Systems, Instruments and Methods of Using The Same, which is incorporated herein by reference in its entirety.FIELD OF THE INVENTION

[0002] The present invention relates generally to general surgery, orthopedic implants used for replacing an articulation surface in a joint, such as knee prostheses. More specifically, but not exclusively, the present invention relates to femoral implants, tibial implants, or unicompartmental knee implants, instruments, and systems for knee replacements and revisions, as well as methods for using the same.BACKGROUND OF THE INVENTION

[0003] Unicompartmental knee arthroplasties are performed to replace a single femoral condyle and a medial or lateral aspect of the tibial plateau. There is minimal space available between the femur and tibia can make it difficult to use the necessary instrumentation for inserting press fit implants into the spaces between the femur and tibia without destabilizing the joint. Due to the difficulty with inserting press fit implants and their instrumentation into the knee joint, many press fit components experience loosening after implantation. In addition, other press fit components may experience loosening due to the failure of initial fixation of the component into a patient’s bone. Therefore, a press fit unicompartmental knee arthroplasty components and instrumentation are needed that achieves solid fixation without the risk of micromotion or loosening after implantation.SUMMARY OF THE INVENTION

[0004] Aspects of the present disclosure provide femoral implants, tibial implants, and / or instrumentation for unicompartmental knee arthroplasty. The present invention also provides for methods for using the femoral implants, tibial implants, and / or instrumentation.

[0005] In one aspect, provided herein is a femoral cut guide including a base plate extending from a first end to a second end and a guide plate coupled to and extending from a superior surface of the base plate.

[0006] In another aspect, provided herein is a spacer for use with a femoral cut guide. The spacer including a base member and a first portion coupled to and extending from theDocket No. : 6323.003A WO base member to a first end, wherein the first portion includes a first protrusion extending from an inferior surface of the first portion.

[0007] In yet another aspect provided herein is a femoral resection assembly including the femoral cut guide and the spacer coupled to an inferior surface of the femoral cut guide.

[0008] In another aspect, provided herein is a fin punch including a base, a punch body extending from a first end of the base, and at least one wing coupled to and extending from an exterior surface of the punch body.

[0009] In still another aspect, provided herein is a tibial resection guide including a base member, a first extension portion extending from a superior end of the base member, and a second extension portion extending from an inferior end of the base member.

[0010] In a further aspect, provided herein is a keel cutter including an attachment member, an arm extending from a first end of the attachment member, a base positioned at a first end of the arm, and a cutting member extending from an inferior end of the base.

[0011] In another aspect, provided herein is a tibial insertion system including a handle, an impaction inserter coupled to an inferior end of the handle, a tibial implant coupled to an inferior end of the impaction inserter, and an implant packaging assembly that receives the impaction inserter and tibial implant.

[0012] In yet another aspect, provided herein is a handle including an arm and an attachment foot coupled to and extending from a second end of the arm.

[0013] In another aspect, provided herein is an impaction inserter including a rim extending around a first end, a first side, and a second side, a superior surface, wherein a portion of the superior surface is surrounded by the rim, and a sidewall extending between the rim and the superior surface.

[0014] In still another aspect, provided herein is a packaging retainer system including an implant, an inserter removably coupled to a superior end of the implant, and a packaging assembly receiving the coupled implant and inserter.

[0015] In yet another aspect, provided herein is a packaging assembly including a base and a tray extending away from a superior surface of the base.

[0016] In a further aspect, provided herein is a tibial stylus assembly including a tibial stylus guide and a stylus slidingly received within a channel of the tibial stylus guide.

[0017] These, and other objects, features and advantages of this invention will become apparent from the following detailed description of the various aspects of the invention taken in conjunction with the accompanying drawings.Docket No. : 6323.003A WOBRIEF DESCRIPTION OF DRAWINGS

[0018] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention and together with the detailed description herein, serve to explain the principles of the invention. The drawings are only for purposes of illustrating preferred embodiments and are not to be construed as limiting the invention. It is emphasized that, in accordance with the standard practice in the industry, various features are not drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or reduced for clarity of discussion. The foregoing and other objects, features and advantages of the invention are apparent from the following detailed description taken in conjunction with the accompanying drawings in which:

[0019] FIG. 1 is a first perspective view of an embodiment of a femoral implant, in accordance with an aspect of the present disclosure;

[0020] FIG. 2 is a second perspective view of the femoral implant of FIG. 1, in accordance with an aspect of the present disclosure;

[0021] FIG. 3 is a first perspective view of an embodiment of a femoral cut guide, in accordance with an aspect of the present disclosure;

[0022] FIG. 4 is a second perspective view of the femoral cut guide of FIG. 3, in accordance with an aspect of the present disclosure;

[0023] FIG. 5 is a first end view of the femoral cut guide of FIG. 3, in accordance with an aspect of the present disclosure;

[0024] FIG. 6 is a second end view of the femoral cut guide of FIG. 3, in accordance with an aspect of the present disclosure;

[0025] FIG. 7 is a superior view of the femoral cut guide of FIG. 3, in accordance with an aspect of the present disclosure;

[0026] FIG. 8 is an inferior view of the femoral cut guide of FIG. 3, in accordance with an aspect of the present disclosure;

[0027] FIG. 9 is a first side view of the femoral cut guide of FIG. 3, in accordance with an aspect of the present disclosure;

[0028] FIG. 10 is a second side view of the femoral cut guide of FIG. 3, in accordance with an aspect of the present disclosure;

[0029] FIG. 11 is a first perspective view of an embodiment of a spacer, in accordance with an aspect of the present disclosure;

[0030] FIG. 12 is a second perspective view of the spacer of FIG. 11, in accordance with an aspect of the present disclosure;Docket No. : 6323.003A WO

[0031] FIG. 13 is a superior view of the spacer of FIG. 11, in accordance with an aspect of the present disclosure;

[0032] FIG. 14 is an inferior view of the spacer of FIG. 11, in accordance with an aspect of the present disclosure;

[0033] FIG. 15 is a first side view of the spacer of FIG. 11, in accordance with an aspect of the present disclosure;

[0034] FIG. 16 is a second side view of the spacer of FIG. 11, in accordance with an aspect of the present disclosure;

[0035] FIG. 17 is a first end view of the spacer of FIG. 11, in accordance with an aspect of the present disclosure;

[0036] FIG. 18 is a second end view of the spacer of FIG. 11, in accordance with an aspect of the present disclosure;

[0037] FIG. 19 is a first perspective view of an embodiment of an assembled femoral cut guide of FIG. 3 and the spacer of FIG. 11, in accordance with an aspect of the present disclosure;

[0038] FIG. 20 is a superior view of the assembled cut guide and spacer of FIG. 19, in accordance with an aspect of the present disclosure;

[0039] FIG. 21 is a first side view of the assembled cut guide and spacer of FIG. 19, in accordance with an aspect of the present disclosure;

[0040] FIG. 22 is a second side view of the assembled cut guide and spacer of FIG. 19, in accordance with an aspect of the present disclosure;

[0041] FIG. 23 is a perspective view of the assembled cut guide and spacer of FIG. 19 positioned on a patient’s knee joint, in accordance with an aspect of the present disclosure;

[0042] FIG. 24 is an exploded perspective view of the cut guide and spacer of FIG. 19 before placement on the patient’s knee joint, in accordance with an aspect of the present disclosure;

[0043] FIG. 25A is a side view of the assembled cut guide and spacer of FIG. 19 positioned within the patient’s knee joint at a first cut angle, in accordance with an aspect of the present disclosure;

[0044] FIG. 25B is a side view of the assembled cut guide and spacer of FIG. 19 positioned within the patient’s knee joint at a second cut angle, in accordance with an aspect of the present disclosure;

[0045] FIG. 26 is a first end view of the assembled cut guide and spacer of FIG. 19 positioned within the patient’s knee joint, in accordance with an aspect of the present disclosure;Docket No. : 6323.003A WO

[0046] FIG. 27 is a perspective view of the cut guide of FIG. 3 with drill bits inserted through the cut guide, in accordance with an aspect of the present disclosure;

[0047] FIG. 28 is an exploded perspective view of the cut guide of FIG. 3 and two femoral punches being inserted into the cut guide, in accordance with an aspect of the present disclosure;

[0048] FIG. 29 is a first perspective view of an embodiment of a fin punch, in accordance with an aspect of the present disclosure;

[0049] FIG. 30 is a second perspective view of the fin punch of FIG. 29, in accordance with an aspect of the present disclosure;

[0050] FIG. 31 is a first side view of the fin punch of FIG. 29, in accordance with an aspect of the present disclosure;

[0051] FIG. 32 is a second side view of the fin punch of FIG. 29, in accordance with an aspect of the present disclosure;

[0052] FIG. 33 is a first end view of the fin punch of FIG. 29, in accordance with an aspect of the present disclosure;

[0053] FIG. 34 is a second end view of the fin punch of FIG. 29, in accordance with an aspect of the present disclosure;

[0054] FIG. 35 is a first perspective view of an embodiment of a tibial implant, in accordance with an aspect of the present disclosure;

[0055] FIG. 36 is a second perspective view of the tibial implant of FIG. 35, in accordance with an aspect of the present disclosure;

[0056] FIG. 37 is a first perspective view of an embodiment of a tibial resection guide, in accordance with an aspect of the present disclosure;

[0057] FIG. 38 is a second perspective view of the tibial resection guide of FIG. 37, in accordance with an aspect of the present disclosure;

[0058] FIG. 39 is a superior view of the tibial resection guide of FIG. 37, in accordance with an aspect of the present disclosure;

[0059] FIG. 40 is an inferior view of the tibial resection guide of FIG. 37, in accordance with an aspect of the present disclosure;

[0060] FIG. 41 is a first end view of the tibial resection guide of FIG. 41, in accordance with an aspect of the present disclosure;

[0061] FIG. 42 is a second end view of the tibial resection guide of FIG. 41, in accordance with an aspect of the present disclosure;

[0062] FIG. 43 is a first side view of the tibial resection guide of FIG. 41, in accordance with an aspect of the present disclosure;Docket No. : 6323.003A WO

[0063] FIG. 44 is a second side view of the tibial resection guide of FIG. 41, in accordance with an aspect of the present disclosure;

[0064] FIG. 45 is an exploded perspective view of the tibial resection guide of FIG. 37 and a comer pin before placement on a tibia with k-wires, in accordance with an aspect of the present disclosure;

[0065] FIG. 46 is a perspective view of the tibial resection guide, comer pin, and k-wires positioned on a tibia of FIG. 45, in accordance with an aspect of the present disclosure;

[0066] FIG. 47 is a perspective view of FIG. 45 after the tibia is cut with the tibial resection guide, in accordance with an aspect of the present disclosure;

[0067] FIG. 48 is an exploded perspective view of the resected tibia of FIG. 47 and the tibial implant of FIG. 35, in accordance with an aspect of the present disclosure;

[0068] FIG. 49 is a perspective view of the tibial implant of FIG. 35 inserted into the resected tibia of FIG. 47, in accordance with an aspect of the present disclosure;

[0069] FIG. 50 is a first perspective view of an embodiment of a keel cutter, in accordance with an aspect of the present disclosure;

[0070] FIG. 51 is a second perspective view of the keel cutter of FIG. 50, in accordance with an aspect of the present disclosure;

[0071] FIG. 52 is a first side view of the keel cutter of FIG. 50, in accordance with an aspect of the present disclosure;

[0072] FIG. 53 is a second side view of the keel cutter of FIG. 50, in accordance with an aspect of the present disclosure;

[0073] FIG. 54 is a superior view of the keel cutter of FIG. 50, in accordance with an aspect of the present disclosure;

[0074] FIG. 55 is an inferior view of the keel cutter of FIG. 50, in accordance with an aspect of the present disclosure;

[0075] FIG. 56 is a first end view of the keel cutter of FIG. 50, in accordance with an aspect of the present disclosure;

[0076] FIG. 57 is a second end view of the keel cutter of FIG. 50, in accordance with an aspect of the present disclosure;

[0077] FIG. 58 is a perspective view of the keel cutter of FIG. 50 positioned on a tibial implant template, in accordance with an aspect of the present disclosure;

[0078] FIG. 59 is a side view of the keel cutter and tibial implant template of FIG. 58 with an overlaid tibial implant of FIG. 35, in accordance with an aspect of the present disclosure;Docket No. : 6323.003A WO

[0079] FIG. 60 is an exploded, first perspective view of an embodiment of a tibial insertion system, in accordance with an aspect of the present disclosure;

[0080] FIG. 61 is an exploded, second perspective view of the tibial insertion system of FIG. 60, in accordance with an aspect of the present disclosure;

[0081] FIG. 62 is an exploded, first side view of the tibial insertion system of FIG. 60, in accordance with an aspect of the present disclosure;

[0082] FIG. 63 is an exploded, second side view of the tibial insertion system of FIG. 60, in accordance with an aspect of the present disclosure;

[0083] FIG. 64 is an exploded, first end view of the tibial insertion system of FIG. 60, in accordance with an aspect of the present disclosure;

[0084] FIG. 65 is an exploded, second end view of the tibial insertion system of FIG. 60, in accordance with an aspect of the present disclosure;

[0085] FIG. 66 is an exploded, superior view of the tibial insertion system of FIG. 60, in accordance with an aspect of the present disclosure;

[0086] FIG. 67 is an exploded, inferior view of the tibial insertion system of FIG. 60, in accordance with an aspect of the present disclosure;

[0087] FIG. 68 is a first perspective view of an embodiment of a packaged tibial tray and inserter, in accordance with an aspect of the present disclosure;

[0088] FIG. 69 is a second perspective view of the packaged tibial tray and inserter of FIG. 68, in accordance with an aspect of the present disclosure;

[0089] FIG. 70 is a superior view of the packaged tibial tray and inserter of FIG. 68, in accordance with an aspect of the present disclosure;

[0090] FIG. 71 is an inferior view of the packaged tibial tray and inserter of FIG. 68, in accordance with an aspect of the present disclosure;

[0091] FIG. 72 is a first, cross-sectional view of the packaged tibial tray and inserter of FIG. 68 taken along line 72—72 in FIG. 70, in accordance with an aspect of the present disclosure;

[0092] FIG. 73 is a second, cross-sectional view of the packaged tibial tray and inserter of FIG. 68 taken along line 73—73 in FIG. 70, in accordance with an aspect of the present disclosure;

[0093] FIG. 74 is a first perspective view of an embodiment of a tibial inserter assembly, in accordance with an aspect of the present disclosure;

[0094] FIG. 75 is a second perspective view of the tibial inserter assembly of FIG. 74, in accordance with an aspect of the present disclosure;Docket No. : 6323.003A WO

[0095] FIG. 76 is a first side view of the tibial inserter assembly of FIG. 74, in accordance with an aspect of the present disclosure;

[0096] FIG. 77 is a second side view of the tibial inserter assembly of FIG. 74, in accordance with an aspect of the present disclosure;

[0097] FIG. 78 is a first end view of the tibial inserter assembly of FIG. 74, in accordance with an aspect of the present disclosure;

[0098] FIG. 79 is a second end view of the tibial inserter assembly of FIG. 74, in accordance with an aspect of the present disclosure;

[0099] FIG. 80 is a first perspective view of a tibial stylus, in accordance with an aspect of the present disclosure;

[0100] FIG. 81 is a second perspective view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0101] FIG. 82 is first side view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0102] FIG. 83 is a second side view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0103] FIG. 84 is superior view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0104] FIG. 85 is an inferior view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0105] FIG. 86 is a first end view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0106] FIG. 87 is a second end view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0107] FIG. 88 is an exploded, first perspective view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0108] FIG. 89 is an exploded, second perspective view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0109] FIG. 90 is an exploded, first side view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0110] FIG. 91 is an exploded, second side view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0111] FIG. 92 is an exploded, first end view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;Docket No. : 6323.003A WO

[0112] FIG. 93 is an exploded, second end view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0113] FIG. 94 is an exploded, superior view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0114] FIG. 95 is an exploded, inferior view of the tibial stylus of FIG. 80, in accordance with an aspect of the present disclosure;

[0115] FIG. 96 is first perspective view of the tibial stylus of FIG. 80 inserted into the tibial resection guide of FIG. 37, in accordance with an aspect of the present disclosure;

[0116] FIG. 97 is a side view of the assembly of FIG. 96, in accordance with an aspect of the present disclosure;

[0117] FIG. 98 is a first end view of the assembly of FIG. 96, in accordance with an aspect of the present disclosure;

[0118] FIG. 99 is a second end view of the assembly of FIG. 96, in accordance with an aspect of the present disclosure;

[0119] FIG 100 is a superior view of the assembly of FIG. 96, in accordance with an aspect of the present disclosure;

[0120] FIG. 101 is an inferior view of the assembly of FIG. 96, in accordance with an aspect of the present disclosure;

[0121] FIG. 102 is a first perspective view of the tibial stylus of FIG. 80 positioned on a superior surface of the tibial resection guide of FIG. 37, in accordance with an aspect of the present disclosure;

[0122] FIG. 103 is a second perspective view of the assembly of FIG. 102, in accordance with an aspect of the present disclosure;

[0123] FIG. 104 is a side view of the assembly of FIG. 102, in accordance with an aspect of the present disclosure;

[0124] FIG. 105 is a first end view of the assembly of FIG. 102, in accordance with an aspect of the present disclosure;

[0125] FIG. 106 is a superior view of the assembly of FIG. 102, in accordance with an aspect of the present disclosure;

[0126] FIG. 107 is an inferior view of the assembly of FIG. 102, in accordance with an aspect of the present disclosure; and

[0127] FIG. 108 is an exploded view of the tibial stylus guide of the assembly of FIG. 102, in accordance with an aspect of the present disclosure.Docket No. : 6323.003A WODETAILED DESCRIPTION FOR CARRYING OUT THE INVENTION

[0128] Generally stated, disclosed herein are femoral implants, tibial implants, and instrumentation for unicompartmental knee arthroplasty. Further, surgical methods for using the femoral implants, tibial implants, and instrumentation are discussed.

[0129] In this detailed description and the following claims, the words proximal, distal, anterior, posterior, medial, lateral, superior and inferior are defined by their standard usage for indicating a particular part of a bone or implant according to the relative disposition of the natural bone or directional terms of reference. For example, “proximal” means the portion of a device or implant nearest the torso, while “distal” indicates the portion of the device or implant farthest from the torso. As for directional terms, “anterior” is a direction towards the front side of the body, “posterior” means a direction towards the back side of the body, “medial” means towards the midline of the body, “lateral” is a direction towards the sides or away from the midline of the body, “superior” means a direction above and “inferior” means a direction below another object or structure.

[0130] Similarly, positions or directions may be used herein with reference to anatomical structures or surfaces. For example, as the current implants, devices, instruments, systems and methods are described herein with reference to use with the bones of the knee, the bones of the knee and leg may be used to describe the surfaces, positions, directions or orientations of the implants, devices, instruments, systems and methods. Further, the implants, devices, instruments, systems and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to one side of the body for brevity purposes. However, as the human body is relatively symmetrical or mirrored about a line of symmetry (midline), it is hereby expressly contemplated that the implants, devices, instruments, systems and methods, and the aspects, components, features and the like thereof, described and / or illustrated herein may be changed, varied, modified, reconfigured or otherwise altered for use or association with another side of the body for a same or similar purpose without departing from the spirit and scope of the invention. For example, the implants, devices, instruments, systems and methods, and the aspects, components, features and the like thereof, described herein with respect to the right knee may be mirrored so that they likewise function with the left knee and vice versa. Further, the implants, devices, instruments, systems and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to the knee for brevity purposes, but it should be understood that the implants, devices, instruments, systems and methods may be used with other bones of the body having similar structures, for example the upper extremity, and more specifically, with the bones of the shoulder, elbow, and arm.Docket No. : 6323.003A WO

[0131] Referring to the drawings, wherein like reference numerals are used to indicate like or analogous components throughout the several views, and with particular reference to FIGS. 1-79, there is illustrated embodiments of a femoral implant 100, a tibial implant 500, and instruments 250, 370, 420, 650, 730, 770, 780, 800, 850 for unicompartmental knee arthroplasty.

[0132] With reference to FIGS. 1-2, an embodiment of the femoral implant 100 and instruments 250, 370, 420 for replacing a single femoral condyle are shown. Specifically, as shown in FIGS. 1-2, the femoral implant 100 includes a first end 102, a second end 104 opposite the first end 102, a first side 106, and a second side 108 opposite the first side 106. The femoral implant 100 may also include an interior surface and an exterior surface. The implant 100 also includes a first portion 110 extending from the first end 102 towards the second end 104, a second portion 130 coupled to and extending from the first portion 110 toward the second end 104, and a third portion 170 coupled to and extending from the second portion 130 to the second end 104. The first portion 110, second portion 130, and third portion 170 of the implant 100 form, for example, a generally U-shaped implant.

[0133] With continued reference to FIGS. 1-2, the first portion or posterior flange 110 includes an exterior surface 112 and an interior surface 114 generally opposite the exterior surface 112. The interior surface 114 may include a porous coating or texture 116 along at least a portion of the interior surface 114. The interior surface 114 may also include a protrusion 118 extending from the first portion 110 at the first end 102.

[0134] The second portion 130 also includes an exterior surface 132 and an interior surface 134 generally opposite the exterior surface 132. The interior surface 134 may include a porous coating or texture 136, for example, across the entire interior surface 134. The second portion 130 also includes a first post 150 extending away from the interior surface 134. The first post 150 includes a stem 152 coupled to and extending from the interior surface 134 and a head 154 extending away from a second end of the stem 152. The first post 150 may also include at least one fin 160 extending away from an exterior surface of the first post 150. The at least one fin 160 may also include a plurality of serrations 162 along the length of the at least one fin 160. The at least one fin 160 may be, for example, three fins 160 positioned around the circumference of the stem 152.

[0135] With continued reference to FIGS. 1-2, the third portion 170 may include an exterior surface 172 and an interior surface 174 generally opposite the exterior surface 172. The third portion 170 also includes a second post 190 extending away from the interior surface 174. The second post 190 includes a stem 192 coupled to and extending from the interior surface 174 and a head 194 extending away from a second end of the stem 192. TheDocket No. : 6323.003A WO second post 190 may also include at least one fin 200 extending away from an exterior surface of the second post 190. The at least one fin 200 may also include a plurality of serrations 202 along the length of the at least one fin 200. The at least one fin 200 may be, for example, three fins 200 positioned around the circumference of the stem 192.

[0136] The femoral implant 100 may be, for example, the femoral implant of U.S. Provisional Application No. 63 / 551,589 filed February 9, 2024 and entitled Implants, Systems and Methods of Using the Same (Attorney Docket No. 6323.001P1), which is hereby incorporated herein in its entirety.

[0137] Referring now to FIGS. 3-10 and 19-28, a femoral cut guide 250 is shown. The cut guide 250 includes a superior end 252, an inferior end 254 opposite the superior end 252, a first end 256, a second end 258 opposite the first end 256, a first side 260, and a second side 262 opposite the first side 260. The cut guide 250 includes a base plate 270 and a guide plate 290 extending away from a superior surface of the base plate 270. The base plate 270 may be positioned at the inferior end 254 of the cut guide 250. The guide plate 290 extends from the base plate 270 to the superior end 252 of the cut guide 250.

[0138] The base plate 270 includes a first portion 272 extending from a first end 256 toward a second end 258 and a second portion 282 extending from the first portion 272 to the second end 258. The first portion 272 may include a top member 274, a bottom member 276, and a side member 278 connecting the top member 274 and the bottom member 276. The top member 274 extends from the first end 256 at an angle relative to the inferior end 254 of the cut guide 250 toward the second end 258. The bottom member 276 may have a planar inferior end and an angled superior end, for example, forming a wedge portion. The side member 278 may be positioned, for example, connecting the top member 274 and bottom member 276 on a second side 262 of the cut guide 250.

[0139] The first portion 272 also includes a slot or cutting slot 280 extending into the first portion 272 from the first side 260 between the top member 274 and the bottom member 276 toward the second side 262, as shown in FIGS. 3, 5-7, and 9. The second portion 282 extends from the first portion 272, for example, at the widest portion of the wedge of the bottom member 276 to the second end 258. The slot 280 extends into the first portion 272 of the base plate 270 at an angle relative to the inferior end 254. The second portion 282 may also include a ledge 288 extending away from the second side 262 of the second portion 282, as shown in FIGS. 4, 10 and 20. The ledge 288 extends from the first portion 272 towards the second end 258. The ledge 288 may have, for example, a height smaller than the height of the second portion 282.Docket No. : 6323.003A WO

[0140] With continued reference to FIGS. 3-10 and 19-28, the guide plate 290 includes a first portion 292 coupled to and extending away from the base plate 270, a second portion 310 coupled to and extending from the first portion 292, and a third portion 340 coupled to and extending from the second portion 310. The first portion 292 and the third portion 340 may be positioned, for example, generally perpendicular to the inferior surface 254 of the base plate 270. The second portion 310 may be positioned, for example, between and extend out from the first portion 292 and the third portion 340. The second portion 310 may extend from the first end 256 of the first portion 292 and third portion 340 at an angle relative to the first end 256 of the first and third portions 292, 340. The third portion 340 extends away from the superior end of the second portion 310 to the superior end 252 of the cut guide 250.

[0141] As shown in FIGS. 3-6, 9-10, 19, and 21-28, the first portion 292 of the guide plate 290 includes a coupling member 294 extending from a first end 256 of the cut guide 250. The coupling member 294 may have, for example, a cylindrical shape, hexagonal prism shape, or the like. The coupling member 294 may be, for example, configured to couple to an insertion handle. The coupling member 294 may include, for example, grooves 295 inset into the superior and inferior surfaces of the coupling member 294.

[0142] The first portion 292 also includes a first insertion guide 296 extending away from the first end 256 of the cut guide 250. The first insertion guide 296 and the coupling member 294 overlap where they couple to the first end 256 of the first portion 292. The coupling member 294 may be positioned, for example, superior to the first insertion guide 296. The coupling member 294 may extend perpendicularly from the first portion 292. The first insertion guide 296 may extend, for example, at an angle away from the coupling member 294 toward the inferior end 254 of the cut guide 250. The first insertion guide 296 includes a through hole 298 extending through the entire first insertion guide 296 and the first portion 292. The first insertion guide 296 also includes at least one channel 300 extending through the body of the first insertion guide 296. The at least one channel 300 may be, for example, three channels 300 evenly spaced around the circumference of the body of the first insertion guide 296. The first insertion guide 296 also includes at least one passage 302 extending through the first portion 292 from the first end 256 to the second end 258. The at least one passage 302 may be, for example, three passages 302 equally spaced circumferentially around the exterior surface of the body of the first insertion guide 296. It is also contemplated that the channels 300 and passages 302 may be, for example, unequally spaced around the body of the first insertion guide 296. The channels 300 are aligned with the passages 302 to form a path through the entire first insertion guide 296 and the first portionDocket No. : 6323.003A WO292. The first portion 292 may also include a groove 304 inset into the second side 262 of the cut guide 250, as shown in FIGS. 4-6 and 10.

[0143] The second portion 310 of the guide plate 290 includes a top member 312, a bottom member 314, and a side member 316 connecting the top member 312 and the bottom member 314. The first end of the top member 312 is coupled to and extends from the inferior end of the third portion 340. The first end of the bottom member 314 is coupled to and extends from the superior end of the first portion 292. The top member 312 and the bottom member 314 extend away from the first end 256 of the guide plate 290. The top member 312 and bottom member 314 extends, for example, at an angle from the first end 256 of the guide plate 290. The side member 316 couples the second side of the top member 312 to the second side of the bottom member 314. The second portion 310 includes a slot 318 extending between the top member 312 and the bottom member 314. The slot 318 extends into the second portion 310 from the first side 260 towards the second side 262 until engagement with the side member 316.

[0144] The second portion 310 also includes a second insertion guide 320 extending through the top member 312 and the bottom member 314 to engage the third portion 340. The slot 318 may, for example, bisect the second insertion guide 320. The second insertion guide 320 may extend, for example, at an angle away from the third portion 340 toward the inferior end 254 of the cut guide 250. The second insertion guide 320 includes a through hole 322 extending through the entire second insertion guide 320, the bottom member 314, the top member 312, and the third portion 340. The second insertion guide 320 also includes at least one channel 324 extending through the body of the second insertion guide 320. The at least one channel 324 may be, for example, three channels 324 evenly spaced around the circumference of the body of the second insertion guide 320. The second insertion guide 320 also includes at least one passage 326 extending through the second portion 310 and the third portion 340 from the first end 256 to the second end 258. The at least one passage 326 may be, for example, three passages 326 equally spaced circumferentially around the exterior surface of the body of the second insertion guide 320. It is also contemplated that the channels 324 and passages 326 may be, for example, unequally spaced around the body of the second insertion guide 320. The channels 324 are aligned with the passages 326 to form a path through the entire second insertion guide 320, the second portion 310, and the third portion 340.

[0145] The second portion 310 also includes an opening 328 extending through the bottom member 314, the top member 312, and the third portion 340. The opening 328 may be positioned, for example, inferior to the second insertion guide 320. The opening 328 mayDocket No. : 6323.003A WO have, for example, an oval shape or the like. In addition, the second portion 310 includes a first screw guide 330 extending away from the bottom member 314. The first screw guide 330 is positioned superior to the groove 304. The first screw guide 330 may include a first through hole 332 extending through the first screw guide 330 and the second portion 310. The first screw guide 330 may be, for example, configured or sized and shaped to receive a fastener, screw, or the like to secure the cut guide 250 to the femur.

[0146] With continued reference to FIGS. 3-7, 9-10, 19, 21-24, and 26-28, the third portion 340 is shown. The third portion 340 includes screw guides 342, 346, 350, 354 extending away from the first end 256 of the third portion 340 at various angles. The screw guides 342, 346, 350, 354 may include, for example, a first screw guide 342 positioned on a first side 260 of the third portion 340, a second screw guide 346 positioned on the first side 260 of the third portion 340 and superior to the first screw guide 342, a third screw guide 350 positioned at the superior end 252 of the third portion 340, and a fourth screw guide 354 positioned on the second side 262 of the third portion 340. The first screw guide 342 may include a first through hole 344 extending through the first screw guide 342 and the third portion 340. The second screw guide 346 may include a second through hole 348 extending through the second screw guide 346 and the third portion 340. The third screw guide 350 may include a third through hole 352 extending through the third screw guide 350 and the third portion 340. The fourth screw guide 354 may include a fourth through hole 356 extending through the fourth screw guide 354 and the third portion 340. The screw guides 342, 346, 350, 354 may be, for example, configured or sized and shaped to receive a fastener, screw, or the like to secure the cut guide 250 to the femur. The third portion 340 may also include a cutout 258 extending into the superior end 252. The cutout 258 may have a curved interior surface. The cutout 258 may be, for example, positioned adjacent to the third screw guide 350.

[0147] Referring now to FIGS. 11-26, the spacer 370 is shown. The spacer 370 includes a first end 372, a second end 374 opposite the first end 372, a first side 376, a second side 378 opposite a first side 376, a superior surface 380, and an inferior surface 382 opposite the superior surface 380. The spacer 370 also includes a base member 384 positioned in a middle of the spacer 370. The base member 384 may have, for example, a generally rectangular shape. The base member 384 may also include a first groove 386 extending into a first side 376 of the spacer 370. The first groove 386 may be, for example, curved or arced into the base member 384. The base member 384 may also include a second groove 388 extending into a second side 378 of the spacer 370. The second groove 388 may be, for example, curved or arced into the base member 384.Docket No. : 6323.003A WO

[0148] The spacer 370 also includes a first portion 390 extending away from a first end of the base member 384. The first portion 390 extends from the base member 384 to the first end 372. The first end 372 of the first portion 390 may be, for example, rounded or curved. The first portion 390 includes a first recessed surface 392. The first recessed surface 392 of the first portion 390 is inset from a top surface of the base member 384. The first portion 390 may also include a first attachment member 394, for example, position on or received within the superior surface 380 of the first portion 390. The first attachment member 394 is also positioned near the first end 372. The first attachment member 394 may be, for example, a magnet. The first portion 390 further includes a first protrusion 396 extending away from the inferior surface 382. The first protrusion 396 may be, for example, cylindrical or rounded to engage a portion of the tibia to assist with alignment of the femoral cut guide 250. Specifically, the first protrusion 396 of the spacer 370 assists with maintaining the tension on the guide 250 while also keeping the guide 250 perpendicular to the tibia resection at a number of different flexion angles. In alternative embodiments, the first protrusion 396 may be, for example, spherical to engage a portion of the tibia to assist with alignment of the femoral cut guide 250.

[0149] The spacer 370 further includes a second portion 400 extending away from a second end of the base member 384. The second portion 400 extends from the base member 384 to the second end 374. The second end 374 of the second portion 400 may be, for example, rounded or curved. The second portion 400 includes a second recessed surface 402. The second recessed surface 402 of the second portion 400 is inset from a top surface of the base member 384. The second portion 400 may also include a second attachment member 404, for example, position on or received within the superior surface 380 of the second portion 400. The second attachment member 404 is also positioned near the second end 374. The second attachment member 404 may be, for example, a magnet. The second portion 400 further includes a second protrusion 406 extending away from the inferior surface 382. The second protrusion 406 may be, for example, hemispherical or rounded to engage a portion of the tibia to assist with alignment of the femoral cut guide 250. The second protrusion 406 may be, for example, a different size than the first protrusion 396.

[0150] In alternative embodiments, the first protrusion 396 of the first portion 390 may be, for example, curved or flat and the second protrusion 406 of the second portion 400 may be, for example, curved or flat. It is contemplated that the first and second protrusions 396, 406 may both be curved, as shown, the first and second protrusions 396, 406 may be flat or planar, or the first protrusion 396 may be curved while the second protrusion 406 is flat or planar, or vice versa.Docket No. : 6323.003A WO

[0151] With continued reference to FIGS. 19-26, the spacer 370 is shown coupled to the cut guide 250. The spacer 370 may be coupled to the cut guide 250 by the first or second attachment member 394, 404. In addition, the spacer 370 may be, for example, positioned or aligned relative to the cut guide 250 by aligning the recessed surface or depth stop 392, 402 to the first end of the base plate 270, as shown in FIGS. 19-23. The spacer 370 may be used to assist with aligning the cut guide 250 on the femur, for example, by positioning the femur perpendicular to the tibia before securing the cut guide 250 to the femur. To avoid the cut guide 250 angling during placement on the bones and during use, the spacer 370 is used to align the cut guide 250 perpendicular to the tibia. Specifically, the inferior surface of the cut guide 250 should be positioned parallel to the tibia, for example, the resected tibia. Using the spacer 370 fills the gap forces between the tibia and the femur and allows the tibia and femur to be oriented perpendicular. In addition, the spacer 370 allows for variations in the flexion angle, while keeping the cut guide 250 flush to the femur during use. To maintain the flush position of the cut guide 250, the guide 250 may be, for example, angled approximately 85- 110 degrees.

[0152] Regarding FIGS. 25A-25B, the knee joint is positioned at varying degrees of flexion. For example, in FIG. 25A the knee joint is positioned at 88 degrees of flexion, while in FIG. 25B the knee joint is positioned at 96 degrees of flexion. Thus, although the target degree of flexion is 90 degrees, if the surgeon positions the knee joint at an angle that is greater than or less than 90 degrees, the spacer 370 assists with absorbing the surgeon’s error. In addition, if patient anatomy doesn’t allow for the knee joint to be placed at 90 degrees of flexion, the spacer 370 may also assist with accounting for the difference in flexion. Therefore, if the knee resection is under-flexed, as shown in FIG. 25A, or over-flexed, as shown in FIG. 25B, the spacer 370 absorbs the flexion angle discrepancies.

[0153] Referring now to FIGS. 27-28, the cut guide 250 may receive at least one drill bit 410, 412 for drilling openings in the femur. The at least one drill bit 410, 412 may be, for example, a first drill bit 410 and a second drill bit 412. The first drill bit 410 may be inserted through the first insertion guide 296. The second drill bit 412 may be inserted, for example, through the second insertion guide 320. Once the openings are drilled through the insertion guides 296, 320, the drill bits 410, 412 may be removed from the cut guide 250 and at least one fin punch 420 may be used next to form the openings for the posts 150, 190 of the femoral implant 100.

[0154] As shown in FIGS. 28-34, a fin punch 420 may include a base 422, an attachment portion 424, and a punch body 432. The base 422 couples the attachment portion 424 on a first end and the punch body 432 on a second end. The attachment portion 424 may includeDocket No. : 6323.003A WO an opening 426 at the distal end of the fin punch 420 extending through the attachment portion 424 and into at least a portion of the base 422. The opening 426 may include threads 428 extending into the opening 426. The punch body 432 extends away from the second end of the base 422. The punch body 432 extends from the base 422 to the insertion end 430. The insertion end 430 may be, for example, hemispherical or rounded. The fin punch 420 also includes wings 434 extending from the exterior surface of the punch body 432. The fin punch 420 may include, for example, three wings 434 positioned circumferentially around the punch body 432. The wings 434 may extend from the insertion end 430 to a portion of the base 422. The wings 434 may have, for example, angled or tapered proximal ends.

[0155] As shown in FIG. 28, the wings 434 are positioned on the fin punch 420 to align with the channels 300, 324 and passages 302, 326 of the insertion guide 296, 320. The fin punches 420 are used with the cut guide 250 for creating openings in the dense bone of the femur for receiving posts 150, 190 of the femoral implant 100.

[0156] A method of using the cut guide 250 may include placing the guide 250 on the femur. The method may also include inserting fasteners or screws through one or more of the screw guides 330, 342, 346, 350, 354. Next, drill bits 410, 412 may be inserted through the insertion guides 296, 320 for drilling openings in the femur. Then, the fin punches 420 are inserted through the insertion guides 296, 320 and the fin punches 420 are impacted until fully seated within the cut guide 250 forming openings in the femur. One or more of the fin punches 420 may be left in the femur to provide stability for the cut guide 250. Then, additional drilling, punching, and / or cutting may be performed using the cut guide 250. Once all drilling, punching, and cutting is complete, the cut guide 250 may be removed from the femur.

[0157] With reference to FIGS. 35-79, an embodiment of the tibial implant 500 and instruments 650, 730, 770, 780, 800, 850 for replacing a single tibial aspect are shown.

[0158] As shown in FIGS. 35-36, the tibial implant 500 includes a first end 502, a second end 504 opposite the first end 502, a first side 506, a second side 508 opposite the first side 506, a superior surface 510, and an inferior surface 512 opposite the superior surface 510. The first side 506 and the inferior surface 512 are configured to engage a portion of a patient’s tibia. The tibial implant 500 also includes a plate 520 with two posts 550, 570 and a keel 590 extending away from the inferior surface 512 of the implant 500.

[0159] As shown in FIGS. 35-36, the plate 520 includes a recessed region 522 extending into the plate 520 from the superior surface 510 of the implant 500 towards the inferior surface 512. The recessed region 522 may include an upper edge 524 extending from the superior surface 510 into the recessed region 522 and positioned near the first end 502. TheDocket No. : 6323.003A WO recessed region 522 may also include a lower edge or first lip 526 extending from the upper edge 524 to a bottom surface of the recessed region 522. The recessed region 522 may further include a second lip 528 recessed into the outer rim 523 of the plate 520 from the recessed region 522 towards the second end 504. The first lip 526 and the second lip 528 may be, for example, configured and / or sized and shaped to engage and retain an inserter 800, as well as an implant insert (not shown).

[0160] A porous coating may also fill and / or extend from an inferior recess 534. The inferior recess 534 may be, for example, inset into the inferior surface 512 of the implant 500. The porous coating of the inferior recess 534 may extend to and engage the porous region 532 on the first side 506 of the implant 500. Where the porous region 532 engages the porous coating of the inferior recess 534 may form a rounded edge 540. The rounded edge 540 may assist with preventing sitting up of the implant 500 on the prepared bone corner. The plate 520 may further include a posterior pivot end 536 at the second end 504 of the implant 500. The posterior pivot end 536 may be, for example, a rounded or curved end.The pivot end 536 may be, for example, made of a solid metal to promote sliding and rolling of the implant 500 into plate within a patient’s bone.

[0161] Referring now to FIGS. 35-36, the first post 550 extends away from the inferior recess 534 of the plate 520 and the interior surface 512 of the implant 500. The first post 550 includes a stem 552 coupled to and extending from the inferior recess 534 and a head 554 extending away from a second end of the stem 552. The stem 552 may also, for example, be coated with a porous coating 562. The first post 550 may also include at least one fin 564 extending away from an exterior surface of the first post 550. The at least one fin 564 may be, for example, three fins 564 positioned around the circumference of the stem 552. The three fins 564 may be positioned on, for example, the anterior side, the medial side, and the lateral side of the first post 550.

[0162] With continued reference to FIGS. 35-36, a second post 570 extends away from the inferior recess 534 of the plate 520 and the interior surface 512 of the implant 500. The second post 570 includes a stem 572 coupled to and extending from the inferior recess 534 and a head 574 extending away from a second end of the stem 572. The stem 572 may also, for example, be coated with a porous coating 582. The second post 570 may also include at least one fin 584 extending away from an exterior surface of the second post 570. The at least one fin 584 may be, for example, three fins 584 positioned around the circumference of the stem 572. The three fins 584 may be positioned on, for example, the anterior side, the medial side, and the lateral side of the second post 570.Docket No. : 6323.003A WO

[0163] As shown in FIG. 36, the implant 500 also includes a keel 590. The keel 590 includes a first end, anterior end, or leading edge 592 and a second end, posterior end, or trailing edge 594. The keel 590 also includes a distal posterior aspect 596 that is positioned near the second end 504. The second end 594 also includes a recess 598 inset into a portion of the keel 590 at the second end 594. The keel 590 further includes a band member 600. The keel 590 also includes a first protrusion 602 on the first side of the keel 590 and a second protrusion 612 on a second side of the keel 590. The first protrusion 602 may extend from the first end 592 of the keel 590 to a first anterior posterior aspect 604 near the second end 504 of the implant 500. The first anterior posterior aspect 604 tapers into the inferior surface 512 of the implant 500. The first protrusion 602 may be coupled to the interior recess 534 near the protrusion 538. The first protrusion 602 extends from a first end 592 to a second end 594, for example, the protrusion 602 may be angled between the first end 592 and the second end 594. A first porous region 606 may be positioned inferior to the first protrusion 602 and a second porous region 608 may be, for example, positioned superior to the first protrusion 602. In addition, the keel 590 includes at least one first fin 610 coupled to and extending from the keel 590. The at least one fin 610 may be, for example, four fins. The at least one fin 610 extends from the interior surface 512 of the implant 500 to a position near the first protrusion 602. In addition, the distal posterior aspect 596 is positioned more anterior than the first and second anterior posterior aspects 604, 614.

[0164] With continued reference to FIGS. 35-36, the second protrusion 612 may extend from the first end 592 of the keel 590 to a second anterior posterior aspect 614 near the second end 504 of the implant 500. The second anterior posterior aspect 614 may taper into the inferior surface 512 of the implant 500. The second protrusion 612 may be coupled to the interior recess 534 near the protrusion 538. The second protrusion 612 extends from a first end 592 to a second end 594, for example, the protrusion 612 may be angled between the first end 592 and the second end 594. A first porous region 616 may be positioned inferior to the second protrusion 612 and a second porous region 618 may be, for example, positioned superior to the second protrusion 612. In addition, the keel 590 includes at least one second fin 620 coupled to and extending from the keel 590. The at least one second fin 620 may be, for example, four fins.

[0165] The tibial implant 500 may be, for example, the tibial implant of U.S. Provisional Application No. 63 / 551,825 filed February 9, 2024 and entitled Implants, Systems and Methods of Using the Same (Attorney Docket No. 6323.002P1), which is hereby incorporated herein in its entirety.Docket No. : 6323.003A WO

[0166] Referring now to FIGS. 37-47, the tibial resection guide 650 is shown. The tibial resection guide 100 includes a superior surface 652, an inferior surface 654 opposite the superior surface 652, a first end 656, a second end 658 opposite the first end 656, a first side 660, and a second side 662 opposite the first side 660. The resection guide 650 includes a base member 670, a first extension portion 680 extending away from an inferior end of the base member 670, and a second extension portion 700 extending away from a superior end of the base member 670. The base member 670 includes a first opening 672, a second opening 674, and a hole 676 each extending through the base member 670 from the first end 656 to the second end 658. The first opening 672 is positioned superior to the second opening 674. The first and second openings 672, 674 may be positioned near the first side 660 of the resection guide 650. The hole 676 is positioned near the second side 662 of the resection guide 650. The openings 672, 674 may be positioned, for example, adjacent to the hole 676.

[0167] The first extension portion 680 may extend from the superior end of the base member 670. The first extension portion 680 includes a top member 682, a bottom member 684, and a side member 686 connecting the top member 682 to the bottom member 684. A portion of the top member 682, a portion of the bottom member 684, and the side member 686 extend from the first side 660 of the base member 670. The other portion of the top member 682 and the other portion of the bottom member 684 are positioned directly superior to the base member 670. The top member 682 and the bottom member 684 may be, for example, curved on the first end 656 and the second end 658 to match the shape of the tibial bone. The top member 682 and the bottom member 684 are separated by a slot 688. The slot 688 extends into the top member 682 and between the top member 682 and bottom member 684 until the slot 668 reaches the stop 690 in the side member 686.

[0168] The first extension portion 680 may also include an extension member 692 extending from the base member 670 on the second side 662. The superior surface of the extension member 692 may have a curved edge. The first extension portion 680 may also include a curved end or comer hole 694 positioned where the extension member 692, top member 682, and bottom member 684 convene on the second side 662 of the resection guide 650. The curved end 694 extends through the first extension portion 680 from the first end 656 to the second end 658. The curved end 694 may be, for example, configured or sized and shaped to receive a comer pin 710. The curved end 694 and comer pin 710 assist with preventing over cutting of the tibia when a sagittal saw is used in slot 688 and when a reciprocating saw is used in the opening through the top member 682. Specifically, the comer hole 694 is located such that the comer hole 694 is tangent with the cut surfaces of the slot 688 and the extension member 692. This will result in the pin 710 creating a radius inDocket No. : 6323.003A WO the corner, as shown in FIG. 48. The radius helps to reduce stress concentrations in the comer. Additionally, the implant 500 has a matching radius in the corner 532 which ensures a snug fit against the prepared surface of the tibia. This prevents the implant 500 from being held up by the comer radius when inserted. The comer 532 also allows the pin 710 to act as a preparation instrument, if used. Further, the middle of the vertical cut slot adjacent to the extension member 692 and the middle of the horizontal cut slot 688 are offset from each other at the corner hole 694.

[0169] The second extension portion 700 may extend from the inferior end of the base member 670. The second extension portion 700 may include an extension member 702 and a body 704. The extension member 702 may be coupled to the base member 670 on a first end and a body 704 on a second end. The extension member 702 may be, for example, curved as it extends between the base member 670 and the second extension portion 700. The extension member 702 couples to the superior surface 652 on the first side 660. The body 704 may include a through hole 706 extending through the body 704 from the first end 656 to the second end 658. The body 704 may have, for example, a rectangular shape. The body 704 may also include a groove 708 inset into the superior surface 652 of the body 704. The groove 708 may extend between the first side 660 and the second side 662.

[0170] A method of cutting the tibial bone is shown in FIGS. 45-49. The method includes positioning the resection guide 650 onto a tibial bone using k-wires 714, 716. Then, a comer pin 710 may be inserted into the resection guide 650 between the top member 682 and the extension member 692. Next, a sagittal saw may be inserted into the slot 688 and a horizontal cut completed. In addition, a reciprocating saw may be inserted into the first extension portion 680 between the top member 682 and the extension member 692. Once the cuts are made the resection guide 650 may be removed to expose the resected tibial bone 718. Then, the implant 500 may be inserted into the resected tibial bone 718.

[0171] Referring now to FIGS. 50-59, a keel cutter 730 is shown. The keel cutter 730 includes an attachment member 732, an arm 738, and a cutting member 742. The attachment member 732 may include a first tab 734 extending away from a superior side of the attachment member 732 and a second tab 736 extending away from an inferior side of the attachment member 732. The attachment member 732 may be, for example, configured to engage a tool. The arm 738 extends from the attachment member 732 to the cutting member 742. The arm 738 may be, for example, wider than the width of the attachment member 732. The keel cutter 730 also includes a base 740 coupled to and extending from the second end of the arm 738. The base 740 may have, for example, a width larger than the arm 738 and attachment member 732. The cutting member 742 may be coupled to and extend away fromDocket No. : 6323.003A WO the inferior surface of the base 740. The cutting member 742 may include a through hole 744 extending through the cutting member 742 from a first side to a second side.

[0172] The cutting member 742 may include a first extension 746 extending from the inferior side of the base 740 near a posterior end and a second extension 748 extending from the inferior side of the base 740 between the first extension 746 and the anterior end. The cutting member 742 also includes a distal-posterior aspect 750. The distal-posterior aspect 750 is positioned more posterior than the first extension or proximal-posterior aspect 746. The cutting member 742 also includes a first cutting end 752 extending between the first extension 746 and the distal-posterior aspect 750. The cutting member 742 further includes a second cutting end 754 extending from the second extension 748. In addition, the cutting member 742 includes a third cutting end 756 extending between the first cutting end 752 and the second cutting end 754. The keel cutter 730 may further include an opening 758 extending through the base 740 from the superior surface to the inferior surface. The opening 758 extends through the base 740 and into the through hole 744.

[0173] With reference to FIGS. 58-59, a tibial implant template 760 is shown. The keel cutter 730 is received within the tibial implant template 760. The cutting member 742 is received within the cutting opening 762 of the tibial implant template 760. The cutting opening 762 allows for translation of the cutting member 742. The keel cutter 730 may be used to form the opening for the keel 590 of the tibial implant 500, as shown in FIG. 59.

[0174] Referring now to FIGS. 60-67, a tibial insertion system 770 is shown. The tibial insertion system 770 includes a handle 780, an impaction shield or inserter 800, a tibial implant 500, and an implant packaging assembly 850. The handle 780 couples to the inserter 800, which couples to the tibial implant 500. The coupled inserter 800 and tibial implant 500 are received within the implant packaging assembly 850.

[0175] The handle 780 includes a first end 782 and a second end 784 opposite the first end 782. The handle 780 includes an arm 786 extending from the first end 782 toward the second end 784. The arm 786 may be, for example, curved between the first end 782 and the second end 784. The handle 780 also includes an attachment foot 788 positioned at the second end 784 of the handle 780. The attachment foot 788 also includes a tab 790 extending away from a first end of the handle 780. The tab 790 also extends between the first side and the second side of the attachment foot 788. In addition, the attachment foot 788 includes an inferior end with an engagement surface 792 positioned near a first end of the attachment foot 788. The attachment foot 788 also includes a first recess 794 and a second recess 796 inset into the inferior surface of the handle 780. The recesses 794, 796 are positioned adjacent to each other and next to the engagement surface 792. The engagement surface 792 andDocket No. : 6323.003A WO recesses 794, 796 on the inferior surface of the handle 780 are configured to engage the superior surface of the inserter 800. The handle 780 also includes a coupling protrusion 798 positioned near the second end of the handle 780. The coupling protrusion 798 is configured to engage the inserter 800.

[0176] With continued reference to FIGS. 60-67, the inserter 800 is shown. The inserter 800 includes a first end 802, a second end 804 opposite the first end 802, a first side 806, and a second side 808 opposite the first side 806. The first end 802 may have, for example, a first curvature as the first end 802 extends between the first side 806 and the second side 808. The second end 804 may, for example, extend between the first side 806 and the second side 808 with several planar or straight surfaces of varying lengths. For example, the first side 806 may have a length shorter than the second side 808 and the insertion recess 814 may have a length larger than both the first and second sides 806, 808. The first side 806 may be, for example, planar or straight as the first side 806 extends between the first end 802 and the second end 804 of the inserter 800. The second side 808 may have, for example, a first portion that is planar or straight as the first portion extends from the first end 802 and a second portion that had a second curvature as the second portion extends from the first portion to the second end 804. The second curvature may be, for example, larger than the first curvature. The first portion of the second side 808 and the corresponding portion of the first side 806 may form, for example, a handle member to allow for handling of the implant 500 without the surgeon or surgical staff directly touching the implant 500. The handle member provided by the inserter 800 helps to reduce exposure of the implant 500 to any potential outside contamination.

[0177] The inserter 800 may be, for example, a piece of plastic packaging material that is pre-assembled to the implant 500. The inserter 800 may be created by, for example, thermoforming. The inserter 800 may be made of, for example, a thermoplastic polyester, such as, polyethylene terephthalate glycol (PETG) or a similar material. The inserter 800 may retain the implant 500 during insertion of the implant 500 into a patient.

[0178] The inserter 800 includes a rim 810 extending around the first end 802, the first side 806, and the second side 808 of the inserter 800. The rim 810 extends around a portion of a superior surface 812 and the superior surface 812 is coupled to the rim 810 by a sidewall 813. The sidewall 813 may, for example, increase the rigidity of the inserter 800 for assisting with insertion of the implant 500 into a patient. The rim 810 and sidewall 813 are coupled together at a superior end of the sidewall 813. Where the rim 810 and sidewall 813 couple together, the surface is curved. The superior surface 812 may further include an insertion recess 814 positioned at and extending into the second end 804 of the inserter 800. TheDocket No. : 6323.003A WO insertion recess 814 extends through the superior surface 812 and toward an inferior end of the inserter 800. The recess 814 has, for example, a generally rectangular shape as it extends into the inserter 800 from the second end 804 towards the first end 802. The recess 814 also includes an extension 816 extending from a first end of the recess 814 towards the first end 802 of the inserter 800. The extension 816 may have, for example, a width and height that are smaller than the width and height of the recess 814. The recess 814 and extension 816 may be, for example, configured or sided and shaped to receive the attachment foot 788 of the handle 780. The second end 804 of the inserter 800 also includes a passageway 818 extending into the recess 814. Thus, the second end 804 of the inserter 800 does not include the rim 810 or sidewall 813. The recess 814 may be, for example, where force transfer occurs between the handle 780 and the implant 500. For example, the recess 814 may provide a barrier between the metal of the handle 780 and the metal of the implant 500 to prevent a metal-on-metal contact between the handle inserter 780 and the implant 500.

[0179] The inserter 800 also includes a first pocket 820 extending through the superior surface 812 and positioned near the second curvature of the second side 808 of the inserter 800. The first pocket 820 may include a flat or planar first side and a curved second side. The curved second side may, for example, correspond to at least a portion of the second curvature. The first pocket 820 may be, for example, used to prevent the inserter 800 from toggling in the cavity of the implant 500.

[0180] The inserter 800 may further include a second pocket or coupling pocket 822 extending through the superior surface 812. The second pocket 822 may be positioned, for example, near a midpoint of the inserter 800. The second pocket 822 may also be positioned, for example, where the second side 808 transitions from the first portion to the second portion. The second pocket 822 may have, for example, a curved first end and a planar second end. The second pocket 822 may include an undercut 823 extending into the planar portion of the second pocket 822. The second pocket 822 and undercut 823 are configured or sized and shaped to receive and retain a portion of the inferior surface of the attachment foot 788 of the handle 780.

[0181] In addition, the inserter 800 may include an engagement hole 824 positioned near the first end 802 of the inserter 800. The engagement hole 824 may also include, for example, slots extending from the engagement hole 824 to provide flexibility in the inserter 800 to receive the coupling protrusion 798 of the handle 780. There may be, for example, four slots positioned evenly spaced around the circumference of the engagement hole 824. The engagement hole 824 enables, for example, the impactor, inserter or handle 780 to removably clip into the inserter 800.Docket No. : 6323.003A WO

[0182] The inserter 800 also includes a bottom surface 826 with three protrusions 828, 830, 832. The first protrusion 828 is the inferior side of the insertion recess 814 and extends from the second end 804 towards the first end 802. The second protrusion 830 is the inferior side of the first pocket 820 and is positioned adjacent to the first protrusion 828 and the second curvature of the second side 808 of the inserter 800. The third protrusion 832 is the inferior side of the second pocket 822 and is positioned where the second side 808 transitions from the first portion to the second portion. The third protrusion 832 also includes a retention member 834 formed by the undercut 823 of the second pocket 822. The retention member 834 extends from the curved side of the third protrusion 832 towards the first end 802. The inserter 800 further includes a first lip 836 extending along the first side 806 of the bottom surface 826 of the inserter 800. The first lip 836 may extend from the second end 804 toward the first end 802 parallel to the sidewall 813 until the first lip 836 reaches the first end 802 where the first lip 836 engages the sidewall 813. A first groove 838 is formed between the first lip 836 and the sidewall 813. In addition, the inserter 800 includes a second lip 840 extending from the second end 804 of the inserter 800 toward the first end 802. The second lip 840 extends parallel to the sidewall 813 along the curved portion of the second side 808. The second lip 840 engages and couples to the sidewall 813 where the sidewall 813 on the second side 808 changes from curved to straight. A second groove 842 is formed between the second lip 840 and the sidewall 813.

[0183] The retention member 834 is configured or sized and shaped to engage the first lip 526 of the implant 500 and retain the inserter 800 within the recessed region 522 of the implant 500. The second end or tongue of the insertion recess 814 of the inserter 800 engages the second lip 528 of the implant 500. Thus, the retention member 834 of the inserter 800 engages the first lip 526 of the implant 500 and the second end 804 of the inserter 800 engages the second lip 528 of the implant 500 to secure the inserter 800 to the implant 500, as shown in FIGS.68-79. The inserter 800 clips into the lips 526, 528 of the implant 500 to prevent the implant 500 from moving around relative to the inserter 800. The width of the implant 500 between the first side 506 and the second side 508 is the same size or larger than the width of the inserter 800 between the first side 802 and the second side 808. By the inserter 800 having a width equal to or smaller than the width of the implant 500 impingement with soft-tissue or bone is prevented.

[0184] In an alternative embodiment, the inserter 800 may not have a sidewall 813, such that the rim 810 and superior surface 812 form a planar top surface of the inserter 800.

[0185] Referring now to FIGS. 68-73, a packaging retainer system is shown. The packaging retainer system may include an implant 500, an inserter 800, and a packagingDocket No. : 6323.003A WO assembly 850. The implant 500 is inserted into the packaging assembly 850 and the inserter 800 is coupled to the superior surface of the implant 500. The implant 500 may be removed from the packaging assembly 850 by the inserter 800. Specifically, the coupled inserter 800 and implant 500 may be lifted out of the packaging assembly 850 by grabbing the inserter 800 near the first end 802. The packaging assembly 850 may be, for example, thermoformed.

[0186] The packaging assembly 850, as shown in FIGS. 60-73, includes a first end 852, a second end 854 opposite the first end 852, a first side 856, and a second side 858 opposite the first side 856. The packaging assembly 850 includes a base 860 on an inferior side and a tray 862 extending from the base 860 to the superior side of the packaging assembly 850. The base 860 may have, for example, a larger length and width than the tray 862. For example, having a large base 860 may provide additional stability to the packaging assembly 850 when placed on a table or other flat surface. The tray 862 may have an exterior sidewall 864 and an interior sidewall 866. The sidewalls 864, 866 may be, for example, curved on the first end 852, the second end 854, and the second side 858 of the packaging assembly 850. The sidewalls 864, 866 may also be, for example, planar or straight along the first side 856 of the packaging assembly 850. The first end 852 may have a first curvature from the first side 856 towards the second side 858. The first end 852 may also have a second curvature starting at an intermediate position between the first side 856 and second side 858 and extending to an intermediate position of the second side 858 between the first end 852 and the second end 854. The sidewalls 864, 866 may have a third curvature extending between an intermediate position on the second side 858 between the first end 852 and the second end 854 and the first side 856 extending across the second end 854. The first curvature may be, for example, smaller than the second and third curvatures. The second curvature may be, for example, larger than the first curvature and smaller than the third curvature. Further, the third curvature may be, for example, larger than the first and second curvatures.

[0187] As shown in FIG. 66, the tray 862 may also include a first recess 868, a second recess 870, and a third recess 872 extending into the tray 862 from a superior surface within the interior sidewall 866. The first recess 868 may extend a first depth within the tray 862. The first recess 868 may be, for example, positioned in the comer between the first end 852 and the first side 856. The first recess 868 may also have, for example, a generally square or rectangular shape with rounded corners. The second recess 870 may extend a second depth within the tray 862. The second recess 870 may, for example, overlap with the first recess 868 extending from the corner between the first end 852 and the first side 856 to the corner between the second end 854 and the first side 856 on the first side 856. In addition, the second recess 870 may extend to and have a corresponding shape as the second curvature ofDocket No. : 6323.003A WO the interior sidewall 866. The second recess 870 may then, for example, extend toward an intermediate position between the first side 856 and the second side 858 before extending to the second end 854 and across to the interior sidewall 866 at the corner between the first side 856 and the second end 854. Thus, the second recess 870 may be, for example, a generally “P” shaped recess. Finally, the third recess 868 may, for example, extend a third depth within the tray 862. The third recess 872 may, for example, overlap with the first recess 868 and the second recess 870. The third recess 872 may further extend within the entire interior sidewall 866. The third recess 872 may be, for example, a generally “B” shaped recess. At least a portion of the third recess 872 may be, for example, shaped to securely receive the implant 500 within the third recess 872. By securely receiving the implant 500 within the third recess 872 of the packaging assembly 850, rubbing is reduced and transportation durability is improved. The first depth is larger than the second and third depths. In addition, the first depth is larger than the second depth and the second depth is larger than the third depth. Finally, the third depth is smaller than the first and second depths.

[0188] The tray 862 may further include a first protrusion 874 extending away from a superior surface of the second side 858 of the sidewalls 864, 866. The first protrusion 874 may extend from a portion of the third curvature positioned near the second curvature. Therefore, the first protrusion 874 may be, for example, curved. The first protrusion 874 may include a securement member or tab 876 extending from the interior surface of the first protrusion 874 towards the third recess 872, as shown in FIGS. 66 and 70. The securement member 876 may be, for example, configured or sized and shaped to engage a superior surface of the inserter 800 on a second side 808.

[0189] The tray 862 may also include a second protrusion 878 extending away from a superior surface of the first side 856 of the sidewalls 864, 866. The second protrusion 878 may extend along a portion of the first side 856 between the first end 852 and the second end 854. The second protrusion 878 may include a first securement member or first tab 880 and a second securement member or second tab 882 extending from the interior surface of the second protrusion 878 towards the third recess 872, as shown in FIGS. 66, 68, and 70. The first securement member 880 may be, for example, positioned between the first end 852 and the second securement member 882. The second securement member 882 may be, for example, positioned between the first securement member 880 and the second end 854. The first securement member 880 and the second securement member 882 may be spaced apart along the length of the first side 856. The securement members 880, 882 may be, for example, configured or sized and shaped to engage a superior surface of the inserter 800 on a first side 806. The coupled inserter 800 and implant 500 may be released from the packagingDocket No. : 6323.003A WO assembly 850 by applying pressure to the first side 856 and the second side 858 of the sidewalls 864, 866. Specifically, the pressure may be applied to the sidewalls 864, 866 where the securement member 876 of the first protrusion 874 and the securement members 880, 882 of the second protrusion 878 are positioned to release the securement members 876, 880, 882 from the superior surface of the inserter 800. By applying pressure to the tray 862 during removal of the coupled inserter 800 and implant 500, the surgeon or surgical staff avoid accidentally separating the implant 500 from the inserter 800.

[0190] The inferior end of the packaging assembly 850 may include, for example, a first protrusion 884, a second protrusion 886, and a third protrusion 888 extending between the inferior sidewall 890. The first protrusion 884 is the inferior side of the first recess 868. The second protrusion 886 is the inferior side of the second recess 870. The third protrusion 888 is the inferior side of the third recess 872. The first protrusion 884 has a depth larger than the depth of the second and third protrusions 886, 888. The second protrusion 884 has a depth smaller than the first protrusion 884 and larger than the third protrusion 888. The third protrusion 888 has a depth smaller than the first and second protrusions 884, 886.

[0191] The packaging assembly 850 may also include an opening 892 between the coupled implant 500 and inserter 800 and the tray 862, as shown in FIGS. 68 and 70. The opening 892 allows for the introduction of an inert aqueous solution, such as a saline solution. The third recess 872, which is visible through the opening 892, may also act as a “fill line” to provide a visualization regarding how much saline solution should be introduced into the tray 862. Once introduced the saline solution can be wicked into the porous structures of the implant 500 and break the surface tension. The interdigitation of the inert aqueous solution allows for potential faster uptake of biologic material to improve the speed of osseointegration. The aqueous solution may also include biologies, pharmaceuticals, or the similar.

[0192] Referring now to FIGS. 72-73, the implant 500 is positioned within the packaging assembly 850. Specifically, the first post 550 is positioned within the first recess 868 and the second post 570 and keel 590 are positioned within the second recess 870. Each of the first post 550, second post 570 and keel 590 pass through the third recess 872. The third recess 872 receives the inferior end of the plate 520.

[0193] Referring now to FIGS. 74-79, an insertion assembly is shown. The insertion assembly includes an implant 500, an inserter 800, and an impactor or inserter handle 780. The inferior end of the inserter 800 couples to the implant 500 and the superior end of the inserter 800 couples to the handle 780, as described in greater detail above and which will not be described again here for brevity’s sake.Docket No. : 6323.003A WO

[0194] Referring now to FIGS. 80-108, a tibial stylus 900 is shown. The tibial stylus 900 includes a tibial stylus guide 902 and a stylus 940 slidingly received within the guide 902. The guide 902 includes a first end 904, a second end 906 opposite the first end 904, a first side 908, a second side 910 opposite the first side 908, a superior surface 912, and an inferior surface 914 opposite the superior end 912. The guide 902 includes a base 916 with a channel 918 extending through the base 916 from the first end 904 to the second end 906 of the guide 902. The base 916 may have, for example, a peanut shape with curved recesses at or near a midpoint between two curved ends. The channel 918 may extend into the base 916 from the superior surface 912 of the guide 902 toward the inferior surface 914. The channel 918 may have, for example, a first portion with parallel sides and a second portion with a circular cross-sectional shape. The first portion extends into the second portion to form the channel 918.

[0195] The guide 902 also includes a protrusion 920 extending from a first end of the base 916 to the first end 904 of the guide 902. The protrusion 920 may have a curved first end 904 and a flat or planar superior and inferior surface. The protrusion 920 may have a first height and the base 916 may have a second height. The first height may be, for example, smaller than the second height. The guide 902 may also include an opening 922 extending into the inferior surface 914 of a portion of the base 916 and a portion of the protrusion 920. The opening 922 may be, for example, configured or sized and shaped to receive a magnet 932 and a cap 934 to cover and secure the magnet 932 into the guide 902. In an embodiment, the magnet 932 may be, for example, hermetically sealed to the guide 902 with the cap 934. The guide 902 may further include a recess 924 extending into the second end 906 of the base 916 toward the first end 904.

[0196] The guide 902 also includes a securing mechanism 926 extending away from a second end and an inferior end of the base 916. The recess 924 may be positioned between a superior surface of the securing mechanism 926 and an inferior surface of a portion of the base 916. The securing mechanism 926 may have, for example, a rectangular outer shape. The securing mechanism 926 may also include a tab 928 and a passageway 930. The tab 928 extends into an interior of the securing mechanism 926 and may also have, for example, a rectangular shape. The tab 928 may be surrounded by a passageway 930 extending through the securing mechanism 926 from a superior surface to an inferior surface.

[0197] The stylus 940 includes a first end 942 and a second end 944. The stylus 940 includes a central portion 946 with a first measurement portion 952 at the first end 942, and a second measurement portion 956 at the second end 944. The central portion 946 includes a first flat region 948 inset into a first surface of the stylus 940 and a second flat region 950Docket No. : 6323.003A WO inset into a second surface of the stylus 940. The first surface being opposite the second surface. The first measurement portion 952 extends from the central portion 946 at an angle to the first end 942. The first measurement portion 952 may include a first designation 954 indicating the measurement amount of the first measurement portion 952. The second measurement portion 956 extends from the central portion 946 at an angle to the second end 944. The second measurement portion 956 may include a second designation 958 indicating the measurement amount of the second measurement portion 956. The first measurement portion 952 may have a first length and the second measurement portion 956 may have a second length. In an embodiment, the first length may be, for example, larger than the second length. For example, in an embodiment, the first length may be 4 mm and the second length may be 2 mm. The measurement portions 952, 956 may be, for example, tapered from the central portion 946 to the first end 942 and second end 944, respectively.

[0198] As shown in FIGS. 80-87, the central portion 946 of the stylus 940 may be slidingly inserted into the channel 918 of the tibial stylus guide 902. The stylus 940 may be inserted with the first end 942 positioned in the same direction as the first end 904 of the guide 902. Alternatively, the stylus 940 may be inserted with the second end 944 positioned in the same direction as the first end 904 of the guide 902.

[0199] With continued reference to FIGS. 96-101, the tibial stylus 900 is shown inserted into the slot 688 of the tibial resection guide 650. When the guide 902 is inserted into the tibial resection guide 650, the stylus 940 measures the space between the slot 688 of the guide 902 and the selected end 942, 944 of the stylus 940. The recess 924 may be, for example, configured or sized and shaped to allow for the guide 902 to be positioned within the slot 688 and not engage the extension member 692. The guide 902 may be, for example, positioned along any portion of the slot 688 to take the desired measurements.

[0200] With continued reference to FIGS. 102-108, the tibial stylus 900 is shown coupled to the superior surface of the first extension portion 680 of the tibial resection guide 650. When the guide 902 is positioned to couple to the superior surface 912 of the guide 902, the stylus 940 measures the space between the superior surface 912 of the guide 902 and the selected end 942, 944 of the stylus 940. The guide 902 is positioned adjacent to the extension member 692 of the resection guide 650.

[0201] As may be recognized by those of ordinary skill in the art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present disclosure without departing from the scope of the disclosure. The components of the implants, devices, and / or systems as disclosed in the specification, including the accompanying abstract and drawings, may be replaced by alternativeDocket No. : 6323.003A WO component(s) or feature(s), such as those disclosed in another embodiment, which serve the same, equivalent or similar purpose as known by those skilled in the art to achieve the same, equivalent or similar results by such alternative component(s) or feature(s) to provide a similar function for the intended purpose. In addition, the implants, devices, and / or systems may include more or fewer components or features than the embodiments as described and illustrated herein. Accordingly, this detailed description of the currently-preferred embodiments is to be taken in an illustrative, as opposed to limiting of the disclosure.

[0202] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has”, and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes,” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes,” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

[0203] The invention has been described with reference to the preferred embodiments. It will be understood that the operational embodiments described herein are exemplary of a plurality of possible arrangements to provide the same general features, characteristics, and general system operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations.

Claims

Docket No. : 6323.003A WOCLAIMSHaving thus described the preferred embodiments, the invention is now claimed to be:

1. A femoral cut guide, comprising: a base plate extending from a first end to a second end; and a guide plate coupled to and extending from a superior surface of the base plate.

2. The femoral cut guide of claim 1, wherein the base plate comprises: a first portion extending from the first end toward the second end; and a second portion extending from the second end toward the first end.

3. The femoral cut guide of claim 2, wherein the first portion comprises: a top member extending from the first end of the base plate at an angle; a bottom member with a top surface extending from the first end of the base plate at an angle and a bottom surface extending from the first end of the base plate to the second end; a side member positioned on a second side of the base plate and extending between the top member and the bottom member; and a slot extending into a first side of the base plate.

4. The femoral cut guide of claim 3, wherein the second portion extends from the first portion to the second end of the base plate.

5. The femoral cut guide of claim 4, wherein the second portion further comprises: a ledge extending away from a second side of the second portion.

6. The femoral cut guide of claim 3, wherein the guide plate comprises: a first portion coupled to and extending from the base plate; a second portion coupled to and extending from a first end of the first portion; and a third portion coupled to and extending from a first end of the second portion.Docket No. : 6323.003A WO7. The femoral cut guide of claim 6, wherein the first portion comprises: a coupling member extending from a first end of the first portion; and a first insertion guide coupled to and extending from the first end of the first portion.

8. The femoral cut guide of claim 7, wherein the coupling member is positioned superior to and overlapping with a portion of the first insertion guide.

9. The femoral cut guide of claim 7, wherein the first insertion guide comprises: a through hole extending through the first insertion guide and the first portion; a plurality of channels extending through the first insertion guide from an exterior surface to the through hole.

10. The femoral cut guide of claim 9, wherein the plurality of channels is three channels spaced circumferentially around the first insertion guide.

11. The femoral cut guide of claim 9, wherein the first portion further comprises: a plurality of passages extending through the first portion from the first end to a second end of the first portion, wherein the plurality of passages align with the plurality of channels to form openings extending from a first end to a second end of the first insertion guide and through the first portion from the first end to the second end.

12. The femoral cut guide of claim 11, wherein the plurality of passages extend from the through hole of the first insertion guide and the first portion beyond the exterior surface of the first insertion guide.

13. The femoral cut guide of claim 6, wherein the first portion further comprises: a groove inset into a second side of the first portion between the first end and a second end of the first portion.

14. The femoral cut guide of claim 6, wherein the second portion extends anteriorly out from a first end of the first portion and a first end of the third portion at an angle towards a superior end of the guide plate.Docket No. : 6323.003A WO15. The femoral cut guide of claim 6, wherein the second portion comprises: a bottom member with a first end and a second end, wherein the second end is coupled to a first end of the first portion; a top member with a first end and a second end, wherein the second end is coupled to a second end of the third portion; and a side member coupled to and extending between the bottom member and the top member on a second side of the guide plate.

16. The femoral cut guide of claim 15, wherein the second portion further comprises: a slot extending between the top member and the bottom member from a first side of the guide plate to the side member.

17. The femoral cut guide of claim 16, wherein the second portion further comprises: a second insertion guide extending through the second portion.

18. The femoral cut guide of claim 17, wherein the second insertion guide extends from a first end of the third portion and is bisected by the second portion.

19. The femoral cut guide of claim 17, wherein the second insertion guide comprises: a first section extending from the third portion to the top member of the second portion; and a second section coupled to and extending from the bottom member of the second portion.

20. The femoral cut guide of claim 17, wherein the second insertion guide comprises: a through hole extending through the second insertion guide and the top member and bottom member of the second portion; a plurality of channels extending through the second insertion guide from an exterior surface to the through hole.Docket No. : 6323.003A WO21. The femoral cut guide of claim 20, wherein the through hole further extends through the third portion from a first end to a second end.

22. The femoral cut guide of claim 20, wherein the plurality of channels is three channels spaced circumferentially around the second insertion guide.

23. The femoral cut guide of claim 20, further comprising: a plurality of passages extending through the second portion and the third portion.

24. The femoral cut guide of claim 23, wherein the plurality of passages extend through the bottom member, the top member, and the third portion from a first end to a second end.

25. The femoral cut guide of claim 23, wherein the plurality of passages align with the plurality of channels to form openings extending from a first end to a second end of the second insertion guide, through the second portion from a first end to a second end, and through the third portion from a first end to a second end.

26. The femoral cut guide of claim 25, wherein the plurality of passages extend from the through hole through the second insertion guide, the second portion, and the third portion and beyond an exterior surface of the second insertion guide.

27. The femoral cut guide of claim 23, further comprising: an opening extending through the bottom member, the top member, and the third portion from a first end to a second end.

28. The femoral cut guide of claim 27, wherein the opening is positioned superior to the coupling member and the first insertion guide of the first portion.

29. The femoral cut guide of claim 20, wherein the second portion further comprises: a first screw guide coupled to and extending from a first end of the second portion on a second side of the guide plate; andDocket No. : 6323.003A WO a first through hole extending through the first screw guide and the second portion.

30. The femoral cut guide of claim 6, wherein the third portion comprises: a plurality of screw guides coupled to and extending from a first end of the third portion; and a plurality of through holes extending through the plurality of screw guides and the third portion.

31. The femoral cut guide of claim 30, wherein the plurality of screw guides is four screw guides positioned around an outer edge of the third portion.

32. The femoral cut guide of claim 31, wherein a first screw guide and a second screw guide are positioned on a first side of the third portion, wherein a third screw guide is positioned on a superior end of the third portion, and wherein a fourth screw guide is positioned on a second side of the third portion.

33. The femoral cut guide of claim 32, wherein the third portion further comprises: a cutout extending into the superior end of the third portion, wherein the cutout extends through the third portion from a first end to a second end.

34. The femoral cut guide of claim 33, wherein the cutout is positioned between the second screw guide and the third screw guide.

35. A spacer, comprising: a base member; and a first portion coupled to and extending from the base member to a first end, wherein the first portion includes a first protrusion extending from an inferior surface of the first portion.

36. The spacer of claim 35, further comprising: a second portion coupled to and extending from the base member to a second end, wherein the second portion includes a second protrusion extending from an inferior surface of the second portion.Docket No. : 6323.003A WO37. The spacer of claim 36, wherein the first protrusion is smaller than the second protrusion.

38. The spacer of claim 36, wherein at least one of the first protrusion and the second protrusion has a cylindrical shape.

39. The spacer of claim 36, wherein the first portion comprises: a first attachment member secured on a superior surface of the first portion.

40. The spacer of claim 39, wherein the second portion comprises: a second attachment member secured on a superior surface of the second portion.

41. The spacer of claim 40, wherein the first attachment member is a magnet and wherein the second attachment member is a magnet.

42. The spacer of claim 35, wherein a superior surface of the first portion is recessed from a superior surface of the base member, wherein the superior surface of the second portion is recessed from the superior surface of the base member.

43. A femoral resection assembly, comprising: the femoral cut guide of claim 1; and the spacer of claim 35, wherein the spacer is coupled to an inferior surface of the femoral cut guide.

44. The femoral resection assembly of claim 43, wherein an attachment member couples the spacer to an inferior surface of the femoral cut guide.

45. The femoral resection assembly of claim 43, wherein a portion of a base member of the spacer engages a first end of the cut guide.

46. The femoral resection assembly of claim 43, further comprising: at least one drill bit for insertion through at least one insertion guide of the cut guide.Docket No. : 6323.003A WO47. The femoral resection assembly of claim 43, further comprising: at least one fin punch for insertion through at least one insertion guide of the cut guide.

48. A fin punch, comprising: a base; a punch body extending from a first end of the base; and at least one wing coupled to and extending from an exterior surface of the punch body.

49. The fin punch of claim 48, wherein the at least one wing is three wings positioned circumferentially around the punch body, and wherein the wings extend from the base to a position near the first end of the base.

50. The fin punch of claim 48, wherein the punch body has an insertion end at a first end, and wherein the insertion end is rounded.

51. The fin punch of claim 49, further comprising: an attachment portion coupled to and extending from a second end of the base, wherein the attachment portion includes an opening extending into the attachment portion from a second end of the fin punch towards the base.

52. A tibial resection guide, comprising: a base member; a first extension portion extending from a superior end of the base member; and a second extension portion extending from an inferior end of the base member.

53. The tibial resection guide of claim 52, wherein the base member comprises: a first opening extending through the base member from a first end to a second end of the tibial resection guide; a second opening extending through the base member from the first end to the second end of the tibial resection guide; andDocket No. : 6323.003A WO a hole extending through the base member from the first end to the second end of the tibial resection guide.

54. The tibial resection guide of claim 53, wherein the first opening is positioned superior to the second opening.

55. The tibial resection guide of claim 54, wherein the hole is elongated and positioned between the first and second openings and a second side of the tibial resection guide.

56. The tibial resection guide of claim 52, wherein the first extension portion comprises: a top member; a bottom member coupled to and extending from a superior surface of the base member; a side member extending between the top member and the bottom member on a first side of the tibial resection guide; and a slot extending between the top member and the bottom member from a second side to the side member.

57. The tibial resection guide of claim 56, wherein the first extension portion further comprises: an extension member extending from the second side of the base member.

58. The tibial resection guide of claim 57, wherein the slot extends through the first extension portion from a first end to a second end of the tibial resection guide and between the side member and the extension member.

59. The tibial resection guide of claim 57, wherein a superior surface of the extension member extends beyond a superior surface of the top member.

60. The tibial resection guide of claim 57, wherein the bottom member engages the extension member forming a curved end on an interior surface of the bottom member and the extension member.Docket No. : 6323.003A WO61. The tibial resection guide of claim 56, wherein a first end of the top member and the bottom member each have a convex curve, and wherein a second end of the top member and the bottom member each have a concave curve.

62. The tibial resection guide of claim 57, wherein the slot forms a horizontal opening, and wherein a vertical opening extends between the top member and the extension member.

63. The tibial resection guide of claim 52, wherein the second extension portion comprises: an extension member is coupled to and extending from an inferior surface of the base member; and a body is coupled to and extending from an inferior end of the extension member.

64. The tibial resection guide of claim 63, wherein the extension member is curved as the extension member extends from the second side of the base member.

65. The tibial resection guide of claim 63, wherein the body comprises: a through hole extending through the body from a first end to a second end of the tibial resection guide.

66. The tibial resection guide of claim 65, wherein the body comprises: a groove extending into a superior surface of the body.

67. The tibial resection guide of claim 63, wherein the body extends away from the second side of the tibial resection guide.

68. The tibial resection guide of claim 52, further comprising: a comer pin received within a curved end extending through the first extension portion; and at least one k-wire for insertion through at least one opening of the base member.

69. A keel cutter, comprising:Docket No. : 6323.003A WO an attachment member; an arm extending from a first end of the attachment member; a base positioned at a first end of the arm; and a cutting member extending from an inferior end of the base.

70. The keel cutter of claim 69, wherein the attachment member comprises: a first tab extending from a superior end of the attachment member; and a second tab extending from an inferior end of the attachment member.

71. The keel cutter of claim 69, wherein the arm has a width greater than the width of the attachment member.

72. The keel cutter of claim 69, wherein the base has a width greater than the width of the arm.

73. The keel cutter of claim 69, wherein the cutting member comprises: a through hole extending through the cutting member from a first side to a second side.

74. The keel cutter of claim 73, wherein the cutting member comprises: a first extension extending from a first end of the base; a first cutting end extending from the first extension; a second extension extending from an inferior side of the base between the first end and a second end of the base; a second cutting end extending from the second extension; and a third cutting end extending between and coupling the first cutting end and the second cutting end.

75. The keel cutter of claim 74, wherein the first cutting end, the second cutting end, and the third cutting end each include a plurality of cutting members.

76. A tibial insertion system, comprising: a handle; an impaction inserter removably coupled to an inferior end of the handle;Docket No. : 6323.003A WO a tibial implant removably coupled to an inferior end of the impaction inserter; and an implant packaging assembly that receives the impaction inserter and tibial implant.

77. A handle, comprising: an arm; and an attachment foot coupled to and extending from a second end of the arm.

78. The handle of claim 77, wherein the arm is curved from a first end to the attachment foot.

79. The handle of claim 77, wherein the attachment foot comprising: a tab extending from the attachment foot at a second end.

80. The handle of claim 79, wherein the attachment foot further comprises: an engagement surface positioned on an inferior end of the attachment foot and extending from a first end toward a second end of the attachment foot; and a coupling protrusion extending away from the inferior end of the attachment foot near the second end.

81. The handle of claim 80, wherein the attachment foot further comprises: a first recess inset into the inferior end of the attachment foot on a first side between the first end and the second end of the attachment foot; and a second recess inset into the inferior end of the attachment foot on a second side between the first end and the second end of the attachment foot.

82. An impaction inserter, comprising; a rim extending around a first end, a first side, and a second side; a superior surface, wherein a portion of the superior surface is surrounded by the rim; and a sidewall extending between the rim and the superior surface.

83. The impaction inserter of claim 82, further comprising:Docket No. : 6323.003A WO a first end; a second end opposite the first end; a first side; and a second side opposite the first side; wherein the first end has a first curvature as the first end extends between the first side and the second side; wherein the second end extends between the first side and the second side with at least one planar surface; wherein the first side is planar between the first end and the second end; and wherein the second side has a first portion that is planar from the first end and a second portion that has a second curvature between the first portion and the second end.

84. The impaction inserter of claim 83, wherein the second curvature is larger than the first curvature.

85. The impaction inserter of claim 83, further comprising: an insertion recess positioned at and extending into the second end of the inserter and through the superior surface and toward an inferior end of the inserter.

86. The impaction inserter of claim 85, further comprising: a passageway extending into the recess from the second end of the inserter.

87. The impaction inserter of claim 85, further comprising: a first pocket extending through the superior surface and positioned near the second curvature of the second side of the inserter; a second pocket extending through the superior surface near a midpoint of the inserter.

88. The impaction inserter of claim 87, wherein the second pocket comprises: an undercut extending into a planar portion of the second pocket.

89. The impaction inserter of claim 88, further comprising: a retention member extending away from an inferior end of the impaction inserter, wherein the retention member is positioned opposite the undercut.Docket No. : 6323.003A WO90. The impaction inserter of claim 87, further comprising: an engagement hole positioned near the first end of the inserter.

91. The impaction inserter of claim 89, wherein the engagement hole comprises: a plurality of slots extending from the engagement hole.

92. A packaging retainer system, comprising: an implant; an inserter removably coupled to a superior end of the implant; and a packaging assembly receiving the coupled implant and inserter.

93. The packaging retainer system of claim 92, wherein the packaging assembly comprises: a base; and a tray extending away from a superior surface of the base.

94. The packaging retainer system of claim 93, wherein the packaging assembly further comprises: an opening positioned between the coupled implant and inserter and the tray, wherein the opening allows for the introduction of an inert aqueous solution.

95. The packaging retainer system of claim 94, wherein the inert aqueous solution includes at least one of saline, biologies, and pharmaceuticals.

96. A packaging assembly, comprising: a base; and a tray extending away from a superior surface of the base.

97. The packaging assembly of claim 96, wherein the base has a length and a width larger than a length and a width of the tray.

98. The packaging assembly of claim 96, wherein the tray comprises: an exterior sidewall; and an interior sidewall opposite the exterior sidewall.Docket No. : 6323.003A WO99. The packaging assembly of claim 98, wherein the exterior sidewall and the interior sidewall are curved on a first end, a second end, and a second side of the packaging assembly and straight along a first side of the packaging assembly.

100. The packaging assembly of claim 99, wherein the first end has a first curvature from the first side towards the second side, wherein the first end has a second curvature starting at an intermediate position between the first side and the second side and extending to an intermediate position of the second side between the first end and the second end, and a third curvature extending between the intermediate position on the second side between the first end and the second end and the first side extending across the second end.

101. The packaging assembly of claim 100, wherein the first curvature is smaller than the second and third curvatures, wherein the second curvature is larger than the first curvature, wherein the second curvature is smaller than the third curvature, and wherein the third curvature is larger than the first and second curvatures.

102. The packaging assembly of claim 98, wherein the tray comprises: a first recess; a second recess; and a third recess, wherein the first recess, the second recess, and the third recess extend into the tray from a superior surface within the interior sidewall of the packaging assembly.

103. The packaging assembly of claim 102, wherein the first recess extends a first depth within the tray, wherein the second recess extends a second depth within the tray, and wherein the third recess extends a third depth within the tray.

104. The packaging assembly of claim 103, wherein the first depth is larger than the second depth and third depth, wherein the second depth is smaller than the first depth and the second depth is larger than the third depth, and wherein the third depth is smaller than the first depth and second depth.Docket No. : 6323.003A WO105. The packaging assembly of claim 103, wherein the first recess has a generally square shape, wherein the second recess has a generally “P” shape, and wherein the third recess has a generally “B” shape.

106. The packaging assembly of claim 103, wherein the first recess is positioned in a first corner between the first end and the first side, wherein the second recess overlaps with the first recess extending from the first corner between the first end and the first side to a second comer between the second end and the first side on the first side, and wherein the third recess overlaps with the first recess and the second recess.

107. The packaging assembly of claim 102, wherein the tray further comprises: a first protrusion extending away from a superior surface of a second side of the sidewalls; and a second protrusion extending away from a superior surface of a first side of the sidewalls.

108. The packaging assembly of claim 107, wherein the first protrusion includes a securement member extending from an interior surface of the first protrusion towards the third recess; wherein the second protrusion includes a first tab and a second tab extending from an interior surface of the second protrusion towards the third recess.

109. A tibial stylus assembly, comprising: a tibial stylus guide; and a stylus slidingly received within a channel of the tibial stylus guide.

110. The tibial stylus assembly of claim 109, wherein the tibial stylus guide comprises: a base; a protrusion extending away from the base to the first end of the tibial stylus guide; and a securing mechanism extending away from the base to the second end of the tibial stylus guide.

111. The tibial stylus assembly of claim 110, wherein the base comprises:Docket No. : 6323.003A WO a channel extending through the base from the first end to the second end of the guide and into the base from the superior surface of the guide toward the inferior surface.

112. The tibial stylus assembly of claim 111, wherein the channel comprises: a first portion with parallel sides extending from the superior surface towards the inferior surface; and a second portion with a circular cross-sectional shape extending from the first portion towards the inferior surface.

113. The tibial stylus assembly of claim 110, wherein the protrusion comprises: a curved first end; and a planar superior surface; and a planar inferior surface opposite the superior surface.

114. The tibial stylus assembly of claim 113, wherein the tibial stylus guide comprises: an opening extending into the inferior surface of a portion of the base and a portion of the protrusion.

115. The tibial stylus assembly of claim 114, further comprising: a magnet positioned within the opening; and a cap inserted within the opening and receiving the magnet.

116. The tibial stylus assembly of claim 115, wherein the magnet is hermetically sealed to the tibial stylus guide.

117. The tibial stylus assembly of claim 113, the tibial stylus guide further comprises: a recess extending into the second end of the base toward the first end; and a securing mechanism extending away from a second end and an inferior end of the base.Docket No. : 6323.003A WO118. The tibial stylus assembly of claim 117, wherein the recess is positioned between a superior surface of the securing mechanism and an inferior surface of a portion of the base.

119. The tibial stylus assembly of claim 117, wherein the securing mechanism comprises: a tab extending into an interior of the securing mechanism from the second end; and a passageway surrounding the tab and extending through the securing mechanism from a superior surface to an inferior surface.

120. The tibial stylus assembly of claim 112, wherein the stylus comprises: a central portion; a first measurement portion extending from the central portion to a first end; and a second measurement portion extending from the central portion to a second end.

121. The tibial stylus assembly of claim 120, wherein the central portion comprises: a first flat region inset into a first surface of the stylus; and a second flat region inset into a second surface of the stylus, wherein at least one of the first flat region and the second flat region translates along the second portion of the channel.

122. The tibial stylus assembly of claim 121, wherein the first measurement portion extends from the central portion at an angle to the first end, wherein the second measurement portion extends from the central portion at an angle to the second end, and wherein the first measurement portion extends in a first direction and the second measurement portion extends in a second direction, wherein the first direction is opposite the second direction.

123. The tibial stylus assembly of claim 122, wherein the first measurement portion has a first length, wherein the second measurement portion has a second length, and wherein the first length is longer than the second length.Docket No. : 6323.003A WO124. The tibial stylus assembly of claim 110, further comprising: a tibial resection guide, comprising: a base member; a first extension portion extending from a superior end of the base member and including a slot; and a second extension portion extending from an inferior end of the base member.

125. The tibial stylus assembly of claim 124, wherein the securing mechanism is inserted into the slot of the first extension portion.

126. The tibial stylus assembly of claim 115, further comprising: a tibial resection guide, comprising: a base member; a first extension portion extending from a superior end of the base member and including a slot; and a second extension portion extending from an inferior end of the base member.

127. The tibial stylus assembly of claim 126, wherein the protrusion is positioned on a superior surface of the first extension portion and coupled to the first extension portion with the magnet.

128. A femoral cut guide, comprising: a base plate extending from a first end to a second end; and a guide plate coupled to and extending from a superior surface of the base plate.

129. The femoral cut guide of claim 128, wherein the base plate comprises: a first portion extending from the first end toward the second end; and a second portion extending from the second end toward the first end.

130. The femoral cut guide of any one of claims 128-129, wherein the first portion comprises: a top member extending from the first end of the base plate at an angle;Docket No. : 6323.003A WO a bottom member with a top surface extending from the first end of the base plate at an angle and a bottom surface extending from the first end of the base plate to the second end; a side member positioned on a second side of the base plate and extending between the top member and the bottom member; and a slot extending into a first side of the base plate.

131. The femoral cut guide of any one of claims 128-130, wherein the second portion extends from the first portion to the second end of the base plate.

132. The femoral cut guide of any one of claims 128-131, wherein the second portion further comprises: a ledge extending away from a second side of the second portion.

133. The femoral cut guide of any one of claims 128-132, wherein the guide plate comprises: a first portion coupled to and extending from the base plate; a second portion coupled to and extending from a first end of the first portion; and a third portion coupled to and extending from a first end of the second portion.

134. The femoral cut guide of any one of claims 128-133, wherein the first portion comprises: a coupling member extending from a first end of the first portion; and a first insertion guide coupled to and extending from the first end of the first portion.

135. The femoral cut guide of any one of claims 128-134, wherein the coupling member is positioned superior to and overlapping with a portion of the first insertion guide.

136. The femoral cut guide of any one of claims 128-135, wherein the first insertion guide comprises: a through hole extending through the first insertion guide and the first portion;Docket No. : 6323.003A WO a plurality of channels extending through the first insertion guide from an exterior surface to the through hole.

137. The femoral cut guide of any one of claims 128-136, wherein the plurality of channels is three channels spaced circumferentially around the first insertion guide.

138. The femoral cut guide of any one of claims 128-137, wherein the first portion further comprises: a plurality of passages extending through the first portion from the first end to a second end of the first portion, wherein the plurality of passages align with the plurality of channels to form openings extending from a first end to a second end of the first insertion guide and through the first portion from the first end to the second end.

139. The femoral cut guide of any one of claims 128-138, wherein the plurality of passages extend from the through hole of the first insertion guide and the first portion beyond the exterior surface of the first insertion guide.

140. The femoral cut guide of any one of claims 128-139, wherein the first portion further comprises: a groove inset into a second side of the first portion between the first end and a second end of the first portion.

141. The femoral cut guide of any one of claims 128-140, wherein the second portion extends anteriorly out from a first end of the first portion and a first end of the third portion at an angle towards a superior end of the guide plate.

142. The femoral cut guide of any one of claims 128-141, wherein the second portion comprises: a bottom member with a first end and a second end, wherein the second end is coupled to a first end of the first portion; a top member with a first end and a second end, wherein the second end is coupled to a second end of the third portion; and a side member coupled to and extending between the bottom member and the top member on a second side of the guide plate.Docket No. : 6323.003A WO143. The femoral cut guide of any one of claims 128-142, wherein the second portion further comprises: a slot extending between the top member and the bottom member from a first side of the guide plate to the side member.

144. The femoral cut guide of any one of claims 128-143, wherein the second portion further comprises: a second insertion guide extending through the second portion.

145. The femoral cut guide of any one of claims 128-144, wherein the second insertion guide extends from a first end of the third portion and is bisected by the second portion.

146. The femoral cut guide of any one of claims 128-145, wherein the second insertion guide comprises: a first section extending from the third portion to the top member of the second portion; and a second section coupled to and extending from the bottom member of the second portion.

147. The femoral cut guide of any one of claims 128-146, wherein the second insertion guide comprises: a through hole extending through the second insertion guide and the top member and bottom member of the second portion; a plurality of channels extending through the second insertion guide from an exterior surface to the through hole.

148. The femoral cut guide of any one of claims 128-147, wherein the through hole further extends through the third portion from a first end to a second end.

149. The femoral cut guide of any one of claims 128-148, wherein the plurality of channels is three channels spaced circumferentially around the second insertion guide.

150. The femoral cut guide of any one of claims 128-149, further comprising:Docket No. : 6323.003A WO a plurality of passages extending through the second portion and the third portion.

151. The femoral cut guide of any one of claims 128-150, wherein the plurality of passages extend through the bottom member, the top member, and the third portion from a first end to a second end.

152. The femoral cut guide of any one of claims 128-151, wherein the plurality of passages align with the plurality of channels to form openings extending from a first end to a second end of the second insertion guide, through the second portion from a first end to a second end, and through the third portion from a first end to a second end.

153. The femoral cut guide of any one of claims 128-152, wherein the plurality of passages extend from the through hole through the second insertion guide, the second portion, and the third portion and beyond an exterior surface of the second insertion guide.

154. The femoral cut guide of any one of claims 128-153, further comprising: an opening extending through the bottom member, the top member, and the third portion from a first end to a second end.

155. The femoral cut guide of any one of claims 128-154, wherein the opening is positioned superior to the coupling member and the first insertion guide of the first portion.

156. The femoral cut guide of any one of claims 128-155, wherein the second portion further comprises: a first screw guide coupled to and extending from a first end of the second portion on a second side of the guide plate; and a first through hole extending through the first screw guide and the second portion.

157. The femoral cut guide of any one of claims 128-156, wherein the third portion comprises:Docket No. : 6323.003A WO a plurality of screw guides coupled to and extending from a first end of the third portion; and a plurality of through holes extending through the plurality of screw guides and the third portion.

158. The femoral cut guide of any one of claims 128-157, wherein the plurality of screw guides is four screw guides positioned around an outer edge of the third portion.

159. The femoral cut guide of any one of claims 128-158, wherein a first screw guide and a second screw guide are positioned on a first side of the third portion, wherein a third screw guide is positioned on a superior end of the third portion, and wherein a fourth screw guide is positioned on a second side of the third portion.

160. The femoral cut guide of any one of claims 128-159, wherein the third portion further comprises: a cutout extending into the superior end of the third portion, wherein the cutout extends through the third portion from a first end to a second end.

161. The femoral cut guide of any one of claims 128-160, wherein the cutout is positioned between the second screw guide and the third screw guide.

162. A spacer, comprising: a base member; and a first portion coupled to and extending from the base member to a first end, wherein the first portion includes a first protrusion extending from an inferior surface of the first portion.

163. The spacer of claim 162, further comprising: a second portion coupled to and extending from the base member to a second end, wherein the second portion includes a second protrusion extending from an inferior surface of the second portion.

164. The spacer of any one of claims 162-163, wherein the first protrusion is smaller than the second protrusion.Docket No. : 6323.003A WO165. The spacer of any one of claims 162-164, wherein at least one of the first protrusion and the second protrusion has a cylindrical shape.

166. The spacer of any one of claims 162-165, wherein the first portion comprises: a first attachment member secured on a superior surface of the first portion.

167. The spacer of any one of claims 162-166, wherein the second portion comprises: a second attachment member secured on a superior surface of the second portion.

168. The spacer of any one of claims 162-167, wherein the first attachment member is a magnet and wherein the second attachment member is a magnet.

169. The spacer of any one of claims 162-168, wherein a superior surface of the first portion is recessed from a superior surface of the base member, wherein the superior surface of the second portion is recessed from the superior surface of the base member.

170. A femoral resection assembly, comprising: the femoral cut guide of any one of claims 128-161; and the spacer of any one of claims 162-169, wherein the spacer is coupled to an inferior surface of the femoral cut guide.

171. The femoral resection assembly of claim 170, wherein an attachment member couples the spacer to an inferior surface of the femoral cut guide.

172. The femoral resection assembly of any one of claims 170-171, wherein a portion of a base member of the spacer engages a first end of the cut guide.

173. The femoral resection assembly of any one of claims 170-172, further comprising: at least one drill bit for insertion through at least one insertion guide of the cut guide.Docket No. : 6323.003A WO174. The femoral resection assembly of any one of claims 170-173, further comprising: at least one fin punch for insertion through at least one insertion guide of the cut guide.

175. A fin punch, compri sing : a base; a punch body extending from a first end of the base; and at least one wing coupled to and extending from an exterior surface of the punch body.

176. The fin punch of claim 175, wherein the at least one wing is three wings positioned circumferentially around the punch body, and wherein the wings extend from the base to a position near the first end of the base.

177. The fin punch of any one of claims 175-176, wherein the punch body has an insertion end at a first end, and wherein the insertion end is rounded.

178. The fin punch of any one of claims 175-177, further comprising: an attachment portion coupled to and extending from a second end of the base, wherein the attachment portion includes an opening extending into the attachment portion from a second end of the fin punch towards the base.

179. A tibial resection guide, comprising: a base member; a first extension portion extending from a superior end of the base member; and a second extension portion extending from an inferior end of the base member.

180. The tibial resection guide of claim 179, wherein the base member comprises: a first opening extending through the base member from a first end to a second end of the tibial resection guide; a second opening extending through the base member from the first end to the second end of the tibial resection guide; andDocket No. : 6323.003A WO a hole extending through the base member from the first end to the second end of the tibial resection guide.

181. The tibial resection guide of any one of claims 179-180, wherein the first opening is positioned superior to the second opening.

182. The tibial resection guide of any one of claims 179-181, wherein the hole is elongated and positioned between the first and second openings and a second side of the tibial resection guide.

183. The tibial resection guide of any one of claims 179-182, wherein the first extension portion comprises: a top member; a bottom member coupled to and extending from a superior surface of the base member; a side member extending between the top member and the bottom member on a first side of the tibial resection guide; and a slot extending between the top member and the bottom member from a second side to the side member.

184. The tibial resection guide of any one of claims 179-183, wherein the first extension portion further comprises: an extension member extending from the second side of the base member.

185. The tibial resection guide of any one of claims 179-184, wherein the slot extends through the first extension portion from a first end to a second end of the tibial resection guide and between the side member and the extension member.

186. The tibial resection guide of any one of claims 179-185, wherein a superior surface of the extension member extends beyond a superior surface of the top member.

187. The tibial resection guide of any one of claims 179-186, wherein the bottom member engages the extension member forming a curved end on an interior surface of the bottom member and the extension member.Docket No. : 6323.003A WO188. The tibial resection guide of any one of claims 179-187, wherein a first end of the top member and the bottom member each have a convex curve, and wherein a second end of the top member and the bottom member each have a concave curve.

189. The tibial resection guide of any one of claims 179-188, wherein the slot forms a horizontal opening, and wherein a vertical opening extends between the top member and the extension member.

190. The tibial resection guide of any one of claims 179-189, wherein the second extension portion comprises: an extension member is coupled to and extending from an inferior surface of the base member; and a body is coupled to and extending from an inferior end of the extension member.

191. The tibial resection guide of any one of claims 179-190, wherein the extension member is curved as the extension member extends from the second side of the base member.

192. The tibial resection guide of any one of claims 179-191, wherein the body comprises: a through hole extending through the body from a first end to a second end of the tibial resection guide.

193. The tibial resection guide of any one of claims 179-192, wherein the body comprises: a groove extending into a superior surface of the body.

194. The tibial resection guide of any one of claims 179-193, wherein the body extends away from the second side of the tibial resection guide.

195. The tibial resection guide of any one of claims 179-194, further comprising: a comer pin received within a curved end extending through the first extension portion; andDocket No. : 6323.003A WO at least one k-wire for insertion through at least one opening of the base member.

196. A keel cutter, comprising: an attachment member; an arm extending from a first end of the attachment member; a base positioned at a first end of the arm; and a cutting member extending from an inferior end of the base.

197. The keel cutter of claim 196, wherein the attachment member comprises: a first tab extending from a superior end of the attachment member; and a second tab extending from an inferior end of the attachment member.

198. The keel cutter of any one of claims 196-197, wherein the arm has a width greater than the width of the attachment member.

199. The keel cutter of any one of claims 196-198, wherein the base has a width greater than the width of the arm.

200. The keel cutter of any one of claims 196-199, wherein the cutting member comprises: a through hole extending through the cutting member from a first side to a second side.

201. The keel cutter of any one of claims 196-200, wherein the cutting member comprises: a first extension extending from a first end of the base; a first cutting end extending from the first extension; a second extension extending from an inferior side of the base between the first end and a second end of the base; a second cutting end extending from the second extension; and a third cutting end extending between and coupling the first cutting end and the second cutting end.Docket No. : 6323.003A WO202. The keel cutter of any one of claims 196-201, wherein the first cutting end, the second cutting end, and the third cutting end each include a plurality of cutting members.

203. A tibial insertion system, comprising: a handle; an impaction inserter removably coupled to an inferior end of the handle; a tibial implant removably coupled to an inferior end of the impaction inserter; and an implant packaging assembly that receives the impaction inserter and tibial implant.

204. A handle, comprising: an arm; and an attachment foot coupled to and extending from a second end of the arm.

205. The handle of claim 204, wherein the arm is curved from a first end to the attachment foot.

206. The handle of any one of claims 204-205, wherein the attachment foot comprising: a tab extending from the attachment foot at a second end.

207. The handle of any one of claims 204-206, wherein the attachment foot further comprises: an engagement surface positioned on an inferior end of the attachment foot and extending from a first end toward a second end of the attachment foot; and a coupling protrusion extending away from the inferior end of the attachment foot near the second end.

208. The handle of any one of claims 204-207, wherein the attachment foot further comprises: a first recess inset into the inferior end of the attachment foot on a first side between the first end and the second end of the attachment foot; andDocket No. : 6323.003A WO a second recess inset into the inferior end of the attachment foot on a second side between the first end and the second end of the attachment foot.

209. An impaction inserter, comprising; a rim extending around a first end, a first side, and a second side; a superior surface, wherein a portion of the superior surface is surrounded by the rim; and a sidewall extending between the rim and the superior surface.

210. The impaction inserter of claim 209, further comprising: a first end; a second end opposite the first end; a first side; and a second side opposite the first side; wherein the first end has a first curvature as the first end extends between the first side and the second side; wherein the second end extends between the first side and the second side with at least one planar surface; wherein the first side is planar between the first end and the second end; and wherein the second side has a first portion that is planar from the first end and a second portion that has a second curvature between the first portion and the second end.

211. The impaction inserter of any one of claims 209-210, wherein the second curvature is larger than the first curvature.

212. The impaction inserter of any one of claims 209-211, further comprising: an insertion recess positioned at and extending into the second end of the inserter and through the superior surface and toward an inferior end of the inserter.

213. The impaction inserter of any one of claims 209-212, further comprising: a passageway extending into the recess from the second end of the inserter.

214. The impaction inserter of any one of claims 209-213, further comprising:Docket No. : 6323.003A WO a first pocket extending through the superior surface and positioned near the second curvature of the second side of the inserter; a second pocket extending through the superior surface near a midpoint of the inserter.

215. The impaction inserter of any one of claims 209-214, wherein the second pocket comprises: an undercut extending into a planar portion of the second pocket.

216. The impaction inserter of any one of claims 209-215, further comprising: a retention member extending away from an inferior end of the impaction inserter, wherein the retention member is positioned opposite the undercut.

217. The impaction inserter of any one of claims 209-216, further comprising: an engagement hole positioned near the first end of the inserter.

218. The impaction inserter of any one of claims 209-217, wherein the engagement hole comprises: a plurality of slots extending from the engagement hole.

219. A packaging retainer system, comprising: an implant; an inserter removably coupled to a superior end of the implant; and a packaging assembly receiving the coupled implant and inserter.

220. The packaging retainer system of claim 219, wherein the packaging assembly comprises: a base; and a tray extending away from a superior surface of the base.

221. The packaging retainer system of any one of claims 219-220, wherein the packaging assembly further comprises: an opening positioned between the coupled implant and inserter and the tray, wherein the opening allows for the introduction of an inert aqueous solution.Docket No. : 6323.003A WO222. The packaging retainer system of any one of claims 219-221, wherein the inert aqueous solution includes at least one of saline, biologies, and pharmaceuticals.

223. A packaging assembly, comprising: a base; and a tray extending away from a superior surface of the base.

224. The packaging assembly of claim 223, wherein the base has a length and a width larger than a length and a width of the tray.

225. The packaging assembly of any one of claims 223-224, wherein the tray comprises: an exterior sidewall; and an interior sidewall opposite the exterior sidewall.

226. The packaging assembly of any one of claims 223-225, wherein the exterior sidewall and the interior sidewall are curved on a first end, a second end, and a second side of the packaging assembly and straight along a first side of the packaging assembly.

227. The packaging assembly of any one of claims 223-226, wherein the first end has a first curvature from the first side towards the second side, wherein the first end has a second curvature starting at an intermediate position between the first side and the second side and extending to an intermediate position of the second side between the first end and the second end, and a third curvature extending between the intermediate position on the second side between the first end and the second end and the first side extending across the second end.

228. The packaging assembly of any one of claims 223-227, wherein the first curvature is smaller than the second and third curvatures, wherein the second curvature is larger than the first curvature, wherein the second curvature is smaller than the third curvature, and wherein the third curvature is larger than the first and second curvatures.Docket No. : 6323.003A WO229. The packaging assembly of any one of claims 223-228, wherein the tray comprises: a first recess; a second recess; and a third recess, wherein the first recess, the second recess, and the third recess extend into the tray from a superior surface within the interior sidewall of the packaging assembly.

230. The packaging assembly of any one of claims 223-229, wherein the first recess extends a first depth within the tray, wherein the second recess extends a second depth within the tray, and wherein the third recess extends a third depth within the tray.

231. The packaging assembly of any one of claims 223-230, wherein the first depth is larger than the second depth and third depth, wherein the second depth is smaller than the first depth and the second depth is larger than the third depth, and wherein the third depth is smaller than the first depth and second depth.

232. The packaging assembly of any one of claims 223-231, wherein the first recess has a generally square shape, wherein the second recess has a generally “P” shape, and wherein the third recess has a generally “B” shape.

233. The packaging assembly of any one of claims 223-232, wherein the first recess is positioned in a first corner between the first end and the first side, wherein the second recess overlaps with the first recess extending from the first corner between the first end and the first side to a second comer between the second end and the first side on the first side, and wherein the third recess overlaps with the first recess and the second recess.

234. The packaging assembly of any one of claims 223-233, wherein the tray further comprises: a first protrusion extending away from a superior surface of a second side of the sidewalls; andDocket No. : 6323.003A WO a second protrusion extending away from a superior surface of a first side of the sidewalls.

235. The packaging assembly of any one of claims 223-234, wherein the first protrusion includes a securement member extending from an interior surface of the first protrusion towards the third recess; wherein the second protrusion includes a first tab and a second tab extending from an interior surface of the second protrusion towards the third recess.

236. A tibial stylus assembly, comprising: a tibial stylus guide; and a stylus slidingly received within a channel of the tibial stylus guide.

237. The tibial stylus assembly of claim 236, wherein the tibial stylus guide comprises: a base; a protrusion extending away from the base to the first end of the tibial stylus guide; and a securing mechanism extending away from the base to the second end of the tibial stylus guide.

238. The tibial stylus assembly of any one of claims 236-237, wherein the base comprises: a channel extending through the base from the first end to the second end of the guide and into the base from the superior surface of the guide toward the inferior surface.

239. The tibial stylus assembly of any one of claims 236-238, wherein the channel comprises: a first portion with parallel sides extending from the superior surface towards the inferior surface; and a second portion with a circular cross-sectional shape extending from the first portion towards the inferior surface.Docket No. : 6323.003A WO240. The tibial stylus assembly of any one of claims 236-239, wherein the protrusion comprises: a curved first end; and a planar superior surface; and a planar inferior surface opposite the superior surface.

241. The tibial stylus assembly of any one of claims 236-240, wherein the tibial stylus guide comprises: an opening extending into the inferior surface of a portion of the base and a portion of the protrusion.

242. The tibial stylus assembly of any one of claims 236-241, further comprising: a magnet positioned within the opening; and a cap inserted within the opening and receiving the magnet.

243. The tibial stylus assembly of any one of claims 236-242, wherein the magnet is hermetically sealed to the tibial stylus guide.

244. The tibial stylus assembly of any one of claims 236-243, the tibial stylus guide further comprises: a recess extending into the second end of the base toward the first end; and a securing mechanism extending away from a second end and an inferior end of the base.

245. The tibial stylus assembly of any one of claims 236-244, wherein the recess is positioned between a superior surface of the securing mechanism and an inferior surface of a portion of the base.

246. The tibial stylus assembly of any one of claims 236-245, wherein the securing mechanism comprises: a tab extending into an interior of the securing mechanism from the second end; and a passageway surrounding the tab and extending through the securing mechanism from a superior surface to an inferior surface.Docket No. : 6323.003A WO247. The tibial stylus assembly of any one of claims 236-246, wherein the stylus comprises: a central portion; a first measurement portion extending from the central portion to a first end; and a second measurement portion extending from the central portion to a second end.

248. The tibial stylus assembly of any one of claims 236-247, wherein the central portion comprises: a first flat region inset into a first surface of the stylus; and a second flat region inset into a second surface of the stylus, wherein at least one of the first flat region and the second flat region translates along the second portion of the channel.

249. The tibial stylus assembly of any one of claims 236-248, wherein the first measurement portion extends from the central portion at an angle to the first end, wherein the second measurement portion extends from the central portion at an angle to the second end, and wherein the first measurement portion extends in a first direction and the second measurement portion extends in a second direction, wherein the first direction is opposite the second direction.

250. The tibial stylus assembly of any one of claims 236-249, wherein the first measurement portion has a first length, wherein the second measurement portion has a second length, and wherein the first length is longer than the second length.

251. The tibial stylus assembly of any one of claims 236-250, further comprising: a tibial resection guide, comprising: a base member; a first extension portion extending from a superior end of the base member and including a slot; and a second extension portion extending from an inferior end of the base member.Docket No. : 6323.003A WO252. The tibial stylus assembly of any one of claims 236-251, wherein the securing mechanism is inserted into the slot of the first extension portion.

253. The tibial stylus assembly of any one of claims 236-252, further comprising: a tibial resection guide, comprising: a base member; a first extension portion extending from a superior end of the base member and including a slot; and a second extension portion extending from an inferior end of the base member.

254. The tibial stylus assembly of any one of claims 236-253, wherein the protrusion is positioned on a superior surface of the first extension portion and coupled to the first extension portion with the magnet.

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