Multiplanar bone reduction and fixation plate

Abstract

A multiplanar bone reduction and fixation plate includes an elongated first flange contoured to conform to a first surface of a bone, an elongated second flange configured to conform to a second surface of the bone, and an intermediate plate section extending between the first and second flanges. The first flange, second flange, and intermediate plate section each have respective sets of fastener holes for receiving fasteners to affix the plate to the bone. The plate defines multiple planes of attachment, allowing for secure fixation of the bone. The multiplanar design enables the plate to conform to complex bone geometries, providing stable fixation and promoting effective bone healing.

Description

PCT Patent Application Docket No.: 409948-508001 WO MULTIPLANAR BONE REDUCTION AND FIXATION PLATECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to United States (US) provisional application Serial No. 63 / 748,271, filed 22 January 2025, the entire disclosure of which is incorporated by reference as if fully set forth herein in its entirety.FIELD OF THE INVENTION

[0002] The embodiments of the present invention relate generally to bone reduction and fixation plates, and particularly, to multiplanar bone reduction and fixation plates, and, more particularly, to bone reduction and fixation plates having three planes of attachment.BACKGROUND OF THE INVENTION

[0003] Current approaches for stabilizing and reducing fractures in bones have involved the use of various types of fixation plates, including single-planar plates and combined single-planar plates. Single-planar plates are designed to overlay a single surface of a bone and are typically used for simple fractures where the bone fragments are relatively stable. However, these plates can be limited in their ability to provide adequate stability and support for more complex fractures, where the bone fragments are displaced or unstable. Using two single-planar plates, on the other hand, can be planned to overlay multiple surfaces of a bone and can provide greater stability and support for complex fractures but the fasteners can cause bone splintering. These combined plates can be bulky and may require extensive surgical dissection to implant, which can lead to increased trauma and morbidity for the patient.

[0004] One type of plate that has been used is the so-called "bridge plate", which consists of a single planar section that spans the fracture site, with multiple fastener holes for attaching the plate to the bone on either side of the fracture.However, these plates can be limited in their ability to provide adequate support and stability for complex fractures, particularly where the bone fragments are highly displaced or comminuted.

[0005] Other approaches have involved the use of custom -fabricated wires along with single-planar plates that are designed to conform to the specific anatomyPCT Patent Application Docket No.: 409948-508001 WO of the patient's bone by holding with wire and plate. These configurations can be created using computer-aided design and manufacturing techniques or are done during actual surgery, and the wires can provide a high degree of holding but are not designed for long-term use and can dislodge from the patient's bone. These surgeries can be expensive and time-consuming if a repeat surgery is required and may require specialized equipment and expertise to fabricate.

[0006] Previous approaches to bone reduction and fixation have also involved the use of external fixators, which consist of a frame or single-planar bracket that is attached to the bone using pins or screws, and can provide stability and support for the fracture from outside the skin. However, these fixators can be bulky and uncomfortable for the patient, and may require extensive surgical dissection to implant, which can lead to increased trauma and morbidity. Other approaches have involved the use of intramedullary nails, which are inserted into the medullary canal of the bone to provide stability and support for the fracture. However, these nails can be difficult to insert and may require specialized equipment and expertise and may not be suitable for all types of fractures. Previous approaches to bone reduction and fixation have involved a variety of different single-planar plate designs and implantation techniques, but none of these approaches have provided a comprehensive solution that combines the features described in this disclosure.BRIEF SUMMARY OF THE INVENTION

[0007] The following presents a simplified summary of the innovation in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is intended to neither identify key or critical elements of the invention nor delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.

[0008] Example Description of the Problem and Related Art: Orthopedic surgery often involves the stabilization and fixation of fractured bones to ensure proper healing and restoration of function. Traditional bone plates used in these procedures are typically designed to conform to a single plane of the bone, which can limit their effectiveness in complex fractures or in bones with irregular shapes. The need for more adaptable and versatile fixation devices has led to the development of multiplanar bone plates that can conform to multiple surfaces of a bone, providing better stabilization and support.PCT Patent Application Docket No.: 409948-508001 WO

[0009] Fractures in bones such as the clavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpal, and metatarsal present unique challenges due to their varied anatomical structures and the different forces they endure. Conventional fixation plates may not adequately address these challenges, leading to complications such as improper alignment, insufficient stabilization, or delayed healing. As a result, there is a significant demand for innovative fixation solutions that can accommodate the complex geometries of these bones and provide reliable support throughout the healing process.

[0010] The multiplanar bone reduction and fixation plate may include an elongated planar first flange that is contoured to overlay and substantially conform to a first surface of a bone. The first flange may have a first set of orthogonal holes for receiving a first set of orthogonal fasteners. Additionally, the plate can have an elongated second flange configured to overlay and substantially conform to a second surface of the bone, with a second set of orthogonal holes for receiving a second set of orthogonal fasteners. An elongated intermediate plate section may extend between the first and second flanges, featuring a third set of orthogonal screw holes for receiving a corresponding third set of orthogonal fasteners.

[0011] The second flange of the multiplanar bone reduction and fixation plate can comprise first and second flange portions with a window in between, allowing access to a mid-portion of the bone.

[0012] Some examples of the multiplanar bone reduction and fixation plate may have the first flange include first and second sliding screw holes.

[0013] In some embodiments, the techniques described herein relate to a multiplanar bone reduction and fixation plate including: an elongated planar first flange configured to overlay and substantially conform to a first surface of a bone, the first flange having a first set of orthogonal holes defined through the surface thereof for receiving a first set of orthogonal fasteners; an elongated second flange configured to overlay and substantially conform to a second surface of the bone, the second flange having a second set of orthogonal holes defined through the surface thereof for receiving a second set of orthogonal fasteners; and an elongated intermediate plate section extending between the first flange and the second flange, intermediate plate section having a third set of orthogonal screw holes defined through the surface thereof for receiving a corresponding a third set of orthogonal fasteners.PCT Patent Application Docket No.: 409948-508001 WO

[0014] According to some aspects, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the first flange includes first and second sliding screw holes defined through the surface thereof.

[0015] In some embodiments, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the second flange includes first and second flange portions with a window in between for allowing access to a mid-portion of the bone.

[0016] In some aspects, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the intermediate plate section includes first and second intermediate plate sections, the first intermediate plate section extending between the first flange and the first flange portion, and the second intermediate plate section extending between the first flange and the second flange portion.

[0017] In some embodiments, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the first flange includes first and second angled screw holes defined through the surface thereof in the region of the first flange over the window.

[0018] According to some aspects, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the first flange includes first and second sliding screw holes defined through the surface thereof.

[0019] In some embodiments, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the bone is one of a clavicle, a humerus, a radius, and ulna, a rib, a femur, a tibia, a fibula, a metacarpal, a patella, and a metatarsal.

[0020] In some aspects, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the second flange includes first and second flange portions with a window in between for allowing access to a mid-portion of the bone.

[0021] In some embodiments, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the intermediate plate section includes first and second intermediate plate sections, the first intermediate plate section extending between the first flange and the first flange portion, and the second intermediate plate section extending between the first flange and the second flange portion.PCT Patent Application Docket No.: 409948-508001 WO

[0022] According to some aspects, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the first flange includes first and second angled screw holes defined through the surface thereof in the region of the first flange over the window.

[0023] In some embodiments, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the first flange includes first and second sliding screw holes defined through the surface thereof.

[0024] In some aspects, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the first flange includes a counter-arc profile.

[0025] In some embodiments, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the second flange includes first and second flange portions with a window in between for allowing access to a mid-portion of the bone.

[0026] According to some aspects, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the intermediate plate section includes first and second intermediate plate sections, the first intermediate plate section extending between the first flange and the first flange portion, and the second intermediate plate section extending between the first flange and the second flange portion.

[0027] In some embodiments, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the first flange includes first and second angled screw holes defined through the surface thereof in the region of the first flange over the window.

[0028] In some aspects, the techniques described herein relate to a multiplanar bone reduction and fixation plate, wherein the first flange includes first and second sliding screw holes defined through the surface thereof.

[0029] In some embodiments, the techniques described herein relate to an elongated multiplanar plate including: an elongated planar central section contoured to overlay and substantially conform to a surface of a bone and at least one end section extending from the edge thereof and oriented roughly perpendicular to the planar central section with at least one chamfered section extending between the planar central section and the at least one end section, wherein the planar central section, the at least one end section and the at least one chamfered section arePCT Patent Application Docket No.: 409948-508001 WO configured with respective sets of orthogonal fastener holes for receiving fasteners to affix the plate to the bone.

[0030] According to some aspects, the techniques described herein relate to a multiplanar plate, wherein the at least one end section is first and second end sections disposed at opposite ends of the planar central section with a gap between the end sections.

[0031] In some embodiments, the techniques described herein relate to a multiplanar plate, wherein the bone is one of a clavicle, a humerus, a radius, an ulna, a femur, a tibia, a fibula, a rib, a metacarpal, a patella, and a metatarsal.

[0032] In some aspects, the techniques described herein relate to a multiplanar plate, wherein the elongated planar central section includes a counterarc profile.

[0033] In some embodiments, the techniques described herein relate to a multiplanar plate, wherein the at least one end section is first and second end sections disposed at opposite ends of the planar central section with a gap between the end sections.

[0034] According to some aspects, the techniques described herein relate to a multiplanar plate, wherein the elongated planar central section includes first and second angled screw holes in the region of the window.

[0035] In some embodiments, the techniques described herein relate to a multiplanar plate, wherein the elongated planar central section includes first and second sliding screw holes.

[0036] In some embodiments, the technology herein provides a multiplanar bone fixation plate with intermediate plate section. In a brief summary or a brief summary discussion list, the technology disclosed herein can be discussed, for example, in a summary discussion, by reviewing / discussing the following list of features, which can be inter-combined with any other embodiment, detail, aspect, wording, or example disclosed herein:

[0037] Feature 1 : A multiplanar bone reduction and fixation plate (100) comprising: an elongated planar first flange (103) contoured to overlay and substantially conform to a first surface of a bone (B); an elongated second flange (101) configured to overlay and substantially conform to a second surface of the bone (B); and an elongated intermediate plate section (105) extending between the first flange (103) and the second flange (101 ), wherein the first flange (103), thePCT Patent Application Docket No.: 409948-508001 WO second flange (101), and the intermediate plate section (105) are each configured with respective sets of fastener holes (102, 110, 112) for receiving fasteners (107, 109, 111) to affix the plate (100) to the bone (B), and wherein the plate (100) defines three planes of attachment (205, 210, 215).

[0038] Feature 2: The multiplanar bone reduction and fixation plate (100) of feature 1 , wherein the second flange (101 ) comprises first and second flange portions (101 a, 101 b) with a window (108) therebetween for allowing access to a mid-portion (M) of the bone (B).

[0039] Feature 3: The multiplanar bone reduction and fixation plate (100) of feature 2, wherein the intermediate plate section (105) comprises first and second intermediate plate sections (105a, 105b), the first intermediate plate section (105a) extending between the first flange (103) and the first flange portion (101a), and the second intermediate plate section (105b) extending between the first flange (103) and the second flange portion (101b).

[0040] Feature 4: The multiplanar bone reduction and fixation plate (100) of feature 3, wherein the first flange (103) includes first and second angled screw holes (104) defined through a surface thereof in a region over the window (108).

[0041] Feature 5: The multiplanar bone reduction and fixation plate (100) of feature 4, wherein the angled screw holes (104) are configured to receive angled screws (113) at an angulation in a range from about 0 degrees to about 90 degrees, optionally about 0 degrees to about 30 degrees, optionally in a range from about 7.5 degrees to about 22.5 degrees.

[0042] Feature 6: The multiplanar bone reduction and fixation plate (100) of feature 3, wherein the first flange (103) includes first and second sliding screw holes (106) defined through a surface thereof.

[0043] Feature 7: The multiplanar bone reduction and fixation plate (100) of feature 6, wherein the sliding screw holes (106) have an elongated shape allowing for sliding adjustment back and forth in a range from about 0.5 mm to about 5 mm, optionally in a range from about 1.25 mm to about 3.75 mm.

[0044] Feature 8: The multiplanar bone reduction and fixation plate (100) of feature 1 , wherein the first flange (103) comprises a counter-arc profile.

[0045] Feature 9: The multiplanar bone reduction and fixation plate (100) of feature 8, wherein the counter-arc profile has a radius in a range from about 10 mm to about 100 mm, optionally in a range from about 25 mm to about 75 mm.PCT Patent Application Docket No.: 409948-508001 WO

[0046] Feature 10: The multiplanar bone reduction and fixation plate (100) of feature 1 , wherein the plate (100) is contoured for a bone (B) selected from the group consisting of a clavicle, a humerus, a radius, an ulna, a femur, a tibia, a fibula, a rib, a metacarpal, a patella, and a metatarsal.

[0047] Feature 11 : The multiplanar bone reduction and fixation plate (100) of feature 10, wherein the plate (100) is specifically contoured for a clavicle with an overall length in a range from about 50 mm to about 200 mm, optionally in a range from about 75 mm to about 150 mm.

[0048] Feature 12: The multiplanar bone reduction and fixation plate (100) of feature 1, wherein the intermediate plate section (105) includes at least one chamfered section.

[0049] Feature 13: The multiplanar bone reduction and fixation plate (100) of feature 12, wherein the chamfered section has a chamfer angle in a range from about 20 degrees to about 80 degrees, optionally in a range from about 30 degrees to about 60 degrees.

[0050] Feature 14: The multiplanar bone reduction and fixation plate (100) of feature 1 , wherein the plate (100) is fabricated from stainless steel Type 316L.

[0051] Feature 15: The multiplanar bone reduction and fixation plate (100) of feature 1 , wherein the plate (100) has a thickness in a range from about 0.5 mm to about 5 mm, optionally in a range from about 1.25 mm to about 3.75 mm.

[0052] Feature 16: The multiplanar bone reduction and fixation plate (100) of feature 2, wherein the window (108) has a width in a range from about 5 mm to about 50 mm, optionally in a range from about 12.5 mm to about 37.5 mm.

[0053] Feature 17: The multiplanar bone reduction and fixation plate (100) of feature 1, further comprising a distal end (305) in an alternative version (100").

[0054] Feature 18: The multiplanar bone reduction and fixation plate (100) of feature 17, wherein the distal end (305) is configured for extension along the bone (B) in a version (100') without the window (108).

[0055] Feature 19: A bone fixation system comprising: the multiplanar bone reduction and fixation plate (100) of feature 1; and a plurality of fasteners (107, 109, 111, 113) configured for insertion into the orthogonal fastener holes (102, 110, 112) and angled screw holes (104).PCT Patent Application Docket No.: 409948-508001 WO

[0056] Feature 20: The bone fixation system of feature 19, wherein at least one fastener is a locking screw having a diameter in a range from about 1 mm to about 5 mm, optionally in a range from about 1.75 mm to about 3.75 mm.

[0057] Feature 21 : The bone fixation system of feature 20, wherein the locking screw has a double-lead thread with a lead in a range from about 0.2 mm to about 1.5 mm, optionally in a range from about 0.35 mm to about 1 mm.

[0058] Feature 22: The bone fixation system of feature 19, wherein at least one fastener is a cortical variable angle screw (113) allowing for angulation up to 0-90 degrees or up to about 15 degrees.

[0059] Feature 23: The bone fixation system of feature 22, wherein the cortical variable angle screw has a spherical head with a radius in a range from about 0.5 mm to about 3 mm, optionally in a range from about 0.875 mm to about 2 mm.

[0060] Feature 24: The bone fixation system of feature 19, wherein the fasteners include self-tapping tips with flutes spaced at about 120 degrees.

[0061] Feature 25: The bone fixation system of feature 19, wherein the fasteners have hexalobe drive recesses with a depth in a range from about 0.5 mm to about 3 mm, optionally in a range from about 0.875 mm to about 2 mm.

[0062] Feature 26: The bone fixation system of feature 19, wherein the fasteners have lengths in a range from about 5 mm to about 50 mm, optionally in a range from about 12.5 mm to about 37.5 mm.

[0063] Feature 27: The bone fixation system of feature 19, wherein the fasteners are fabricated from stainless steel Type 316L.

[0064] Feature 28: A locking screw for use in a bone fixation system, comprising: a threaded shaft with a double-lead thread; a head with a hexalobe drive recess; and a self-tapping tip with flutes.

[0065] Feature 29: The locking screw of feature 28, wherein the threaded shaft has a major diameter in a range from about 1 mm to about 5 mm, optionally in a range from about 1.75 mm to about 3.75 mm.

[0066] Feature 30: The locking screw of feature 28, wherein the double-lead thread has a pitch in a range from about 0.2 mm to about 1.5 mm, optionally in a range from about 0.35 mm to about 1 mm.

[0067] Feature 31 : The locking screw of feature 28, wherein the self-tapping tip has a relief angle of about 20 degrees.PCT Patent Application Docket No.: 409948-508001 WO

[0068] Feature 32: The locking screw of feature 28, wherein the hexalobe drive recess has an inner diameter in a range from about 0.5 mm to about 3 mm, optionally in a range from about 0.875 mm to about 2 mm.

[0069] Feature 33: The locking screw of feature 28, having an overall length in a range from about 5 mm to about 50 mm, optionally in a range from about 12.5 mm to about 37.5 mm.

[0070] Feature 34: The locking screw of feature 28, further comprising an undercut beneath the head with an axial length.

[0071] Feature 35: A cortical variable angle screw (113) for use in a bone fixation system, comprising: a threaded shaft; a spherical head allowing for variable angulation; a hexalobe drive recess in the head; and a self-tapping tip.

[0072] Feature 36: The cortical variable angle screw (113) of feature 35, wherein the spherical head allows angulation in a range from about 0 degrees to about 90 degrees, optionally 0 degrees to about 30 degrees, optionally in a range from about 7.5 degrees to about 22.5 degrees.

[0073] Feature 37 : The cortical variable angle screw (113) of feature 35, wherein the threaded shaft has a pitch in a range from about 0.2 mm to about 2 mm, optionally in a range from about 0.5 mm to about 1.5 mm.

[0074] Feature 38: The cortical variable angle screw (113) of feature 35, wherein the self-tapping tip has flutes with a relief angle of about 25 degrees.

[0075] Feature 39: The cortical variable angle screw (113) of feature 35, wherein the hexalobe drive recess has a depth in a range from about 0.2 mm to about 4 mm, optionally about 0.2 mm to about 2 mm, optionally in a range from about 0.5 mm to about 1.5 mm.

[0076] Feature 40: The cortical variable angle screw (113) of feature 35, having a major diameter in a range from about 1 mm to about 4 mm, optionally in a range from about 1.5 mm to about 3 mm.

[0077] Feature 41 : A method of reducing and fixing a bone fracture, comprising: positioning a multiplanar bone reduction and fixation plate (100) according to feature 1 over the bone (B); aligning the first flange (103) with a first surface of the bone (B) and the second flange (101 ) with a second surface of the bone (B); and securing the plate (100) to the bone (B) by inserting fasteners (107, 109, 111, 113) through the fastener holes (102, 110, 112) and angled screw holesPCT Patent Application Docket No.: 409948-508001 WO

[0078] Feature 42: The method of feature 41 , further comprising accessing a mid-portion (M) of the bone (B) through a window (108) in the second flange (101).

[0079] Feature 43: The method of feature 41 , wherein inserting the fasteners includes using angled screws (113) at an angle in a range from about 0 degrees to about 90 degrees, optionally about 0 degrees to about 30 degrees, optionally in a range from about 7.5 degrees to about 22.5 degrees.

[0080] Feature 44: The method of feature 41 , further comprising adjusting screw position via sliding screw holes (106) with adjustment in a range from about 0.5 mm to about 5 mm, optionally in a range from about 1.25 mm to about 3.75 mm.

[0081] Feature 45: The method of feature 41 , wherein the bone (B) is a clavicle.

[0082] Feature 46: The method of feature 41 , using fasteners with self-tapping tips.

[0083] Feature 47: Use of the multiplanar bone reduction and fixation plate (100) according to feature 1 for the stabilization of a fractured bone (B).

[0084] Feature 48: The use of feature 47, wherein the fractured bone (B) is selected from the group consisting of a clavicle, a humerus, a radius, an ulna, a femur, a tibia, a fibula, a rib, a metacarpal, a patella, and a metatarsal.

[0085] Feature 49: The use of feature 47, in combination with locking screws having double-lead threads.

[0086] Feature 50: The use of feature 47, in combination with cortical variable angle screws (113) allowing angulation from about 0-90 degree or optionally up to about 15 degrees.

[0087] In some embodiments, the implants disclosed herein can include markings on the implants. According to some aspects, the markings guide the surgeon to the exact site for any action.

[0088] Other implementations are also described and recited herein. These and other features and advantages will be apparent from a reading of the following detailed description and a review of the associated drawings. It is to be understood that both the foregoing general description and the following detailed description are explanatory only and are not restrictive of aspects as claimed.BRIEF DESCRIPTION OF THE DRAWINGS

[0089] Solely for the purpose of illustration, certain embodiments of the present invention are explained using examples in the drawings described below. ItPCT Patent Application Docket No.: 409948-508001 WO should be understood, however, that the invention is not limited to the precise arrangements, dimensions, and configurations shown. In the drawings:

[0090] FIG. 1 A is a perspective view of an exemplary multiplanar bone reduction and fixation plate.

[0091] FIG. 1B shows an exemplary plate of FIG. 1A overlaying a bone.

[0092] FIG. 1C depicts the underside of the plate of FIG. 1A with a plurality of fasteners.

[0093] FIG. 2 is a section view along line A-A (e.g., compare FIG. 1B).

[0094] FIG. 3 depicts another version of a multiplanar plate 100' for attachment to midshaft sections of a bone B (shown overlaying the bone).

[0095] FIG. 4 presents yet another version of a plate 100" configured for overlaying and substantially conforming to one end of a bone B — for example, a configuration suitable for attachment to the distal end of a clavicle, with the first flange 103 having greater area to overlay the superior surface and the second flange 101 contoured to the anterior surface (distal end labeled 305).

[0096] FIG. 5A is a bottom, isometric view of an exemplary multiplanar bone reduction and fixation plate configured for the left clavicle mid-shaft, showing overall dimensions and contour. In FIGS. 5A-5D, millimeters are depicted in brackets while inches are under the bracketed millimeters, and all dimensions are non-limiting examples.

[0097] FIG. 5B is a top view of the plate of FIG. 5A, illustrating the elongated structure, counter-arc profile, and hole placements with exemplary measurements.

[0098] FIG. 5C is a side view of the plate of FIG. 5A, depicting the multiplanar transitions between flanges and intermediate sections.

[0099] FIG. 5D is a cross-sectional view along section A-A of the plate of FIG. 5A, highlighting thickness, hole diameters, and internal profiles in a non-limiting example.

[0100] FIG. 6A is a side elevational view of an exemplary locking screw 405 for use with the multiplanar bone reduction and fixation plate, showing thread and head features.

[0101] FIG. 6B is an enlarged detail view of the screw tip of FIG. 6A, illustrating self-tapping geometry.

[0102] FIG. 6C is (locking screw 405) a cross-sectional view of the screw threads of FIG. 6A, depicting the double-lead profile.PCT Patent Application Docket No.: 409948-508001 WO

[0103] FIG. 6D is an enlarged detail view of the screw head of FIG. 6A, showing the hexalobe drive and locking mechanism.

[0104] FIG. 7A is a side elevational view of an exemplary cortical variable angle screw 505 for use with the multiplanar bone reduction and fixation plate, showing thread, head, and variable angle features.

[0105] FIG. 7B is an enlarged detail view of the screw tip of FIG. 7A, illustrating self-tapping flute geometry.

[0106] FIG. 7C is a cross-sectional view of the screw threads of FIG. 7A, depicting the profile and pitch for the cortical variable angle screw 505.

[0107] FIG. 7D is an enlarged detail view of the screw head of FIG. 7A, showing the spherical underside and hexalobe drive for variable angle locking.

[0108] It should be understood that while different numbers / numbering are / is sometimes used (and sometimes the same numbers) in some of the figures above to describe different embodiments and different aspects of the technology, any number from any figure can be inter-combined with a numbered aspect from any other figures. All trademarks, images, likenesses, words, and depictions in the drawings and the disclosure are plainly in fair use and are provided solely for the purposes of illustration of the invention in view of an urgent need to treat subjects as further discussed in detail below.DETAILED DESCRIPTION OF THE INVENTION

[0109] The subject innovation is now described in some instances, when necessary, with reference to the drawings. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It may be evident, however, that the present invention may be practiced without these specific details. In other instances, well-known structures, methods, and devices are shown in block diagram form or with illustrations in order to facilitate describing the present invention. It is to be appreciated that certain aspects, modes, embodiments, variations and features of the invention are described below in various levels of detail in order to provide a substantial understanding of the present invention.DEFINITIONS

[0110] For convenience, the meaning of some terms and phrases used in the specification, examples, and appended claims, are provided below. Unless stated otherwise, or implicit from context, the following terms and phrases include thePCT Patent Application Docket No.: 409948-508001 WO meanings provided below. The definitions are provided to aid in describing particular embodiments, and are not intended to limit the claimed invention, because the scope of the invention is limited only by the claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. If there is an apparent discrepancy between the usage of a term in the art and its definition provided herein, the definition provided within the specification shall prevail. In general, typical chemical terminology is found in the International Union of Pure and Applied Chemistry GoldBook1. This disclosure is purposefully presented in commonly understood words, known to a person of skill in the art, but Merriam-Webster’s Online Dictionary is used, when appropriate, for terms not specifically demonstrated herein or not known in the art2.

[0111] As used in this specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless the content clearly dictates otherwise. For example, reference to "a cell" includes a combination of two or more cells, and the like.

[0112] As used herein, the term "approximately" or "about" in reference to a value or parameter are generally taken to include numbers that fall within a range of 5%, 10%, 15%, or 20% in either direction (greater than or less than) of the number unless otherwise stated or otherwise evident from the context (except where such number would be less than 0% or exceed 100% of a possible value). As used herein, reference to "approximately" or "about" a value or parameter includes (and describes) embodiments that are directed to that value or parameter. For example, description referring to "about X" includes description of "X".

[0113] As used herein, the term “or” means “and / or.” The term "and / or" as used in a phrase such as "A and / or B" herein is intended to include both A and B; A or B; A (alone); and B (alone). Likewise, the term "and / or" as used in a phrase such as "A, B, and / or C" is intended to encompass each of the following embodiments: A, B, and C; A, B, or C; A or C; A or B; B or C; A and C; A and B; B and C; A (alone); B (alone); and C (alone).

[0114] As used herein, the term "comprising" means that other elements can also be present in addition to the defined elements presented. The use of "comprising" indicates inclusion rather than limitation. The term “including” can be interchanged with “comprising”.PCT Patent Application Docket No.: 409948-508001 WO

[0115] The term "consisting of" refers to compositions, methods, and respective components thereof as described herein, which are exclusive of any element not recited in that description of the embodiment.

[0116] As used herein the term "consisting essentially of" refers to those elements required for a given embodiment. The term permits the presence of additional elements that do not materially affect the basic and novel or functional characteristic(s) of that embodiment of the invention. The term “consisting essentially of” can also be exemplified by plain language provided in the claims.

[0117] The term "statistically significant" or "significantly" refers to statistical significance and generally means a two-standard deviation (2SD) or greater difference.

[0118] As used herein, the term "subject" refers to a mammal, including but not limited to a dog, cat, horse, cow, pig, sheep, goat, rodent, or primate. Subjects can be house pets (e.g., dogs, cats), agricultural stock animals (e.g., cows, horses, pigs, chickens, etc.), laboratory animals (e.g., mice, rats, rabbits, etc.), but are not so limited. Subjects particularly include human subjects in urgent treatment as described herein. The human subject may be a pediatric, adult, or a geriatric subject. The human subject may be of any sex.

[0119] The term “treating” includes prophylactic and / or therapeutic treatments. The term “prophylactic or therapeutic” treatment is art-recognized and includes administration to the host of one or more of the subject compositions and / or application of one or more therapies or surgeries. If this is done prior to clinical manifestation of the unwanted condition (e.g., disease or other unwanted state of the host animal) then the treatment is prophylactic (i.e., it protects the host against developing the unwanted condition), whereas if it is administered after manifestation of the unwanted condition, the treatment is therapeutic, (i.e., it is intended to diminish, ameliorate, or stabilize the existing unwanted condition or side effects thereof).

[0120] As used herein, the terms “treat,” “treatment,” “treating,” or “amelioration” when used in reference to a disease, disorder, or medical condition, refer to therapeutic surgeries or treatments for a condition, wherein the object is to reverse, alleviate, ameliorate, inhibit, slow down or stop the progression or severity of a symptom or condition. The term “treating” includes reducing or alleviating at least one adverse effect or symptom of a condition. Treatment is generally “effective”PCT Patent Application Docket No.: 409948-508001 WO if one or more symptoms or clinical markers are reduced. Alternatively, treatment is “effective” if the progression of a condition is reduced or halted. That is, “treatment” includes not just the improvement of symptoms or markers, but also a cessation or at least slowing of progress or worsening of symptoms that would be expected in the absence of treatment. Beneficial or desired clinical results include, but are not limited to, alleviation of one or more symptom(s), sign(s), diminishment of extent of the deficit, stabilized ( / .e., not worsening) state of a symptom or condition, delay or slowing of onset of symptoms or indications, and an increased lifespan as compared to that expected in the absence of treatment.

[0121] The terms: “decrease”, “reduced”, “reduction”, or “inhibit” are all used herein to mean a decrease by a statistically significant amount. In some embodiments, “reduce,” “reduction" or “decrease" or “inhibit” typically means a decrease by at least 10% as compared to a reference level (e.g., the absence of a given treatment or agent) and can include, for example, a decrease by at least about 10%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, at least about 98%, at least about 99% , or more. As used herein, “reduction” or “inhibition” does not encompass a complete inhibition or reduction as compared to a reference level. “Complete inhibition” is a 100% inhibition as compared to a reference level. A decrease can be preferably down to a level accepted as within the range of normal for an individual without a given disorder.

[0122] In some embodiments, the decrease in the one or more signs or symptoms is evaluated according to a specialized healthcare provider. In some embodiments, signs are observed or measured by a health care provider. Symptoms can be reported by the subject. In some embodiments, the decrease of signs or symptoms occurs in less than about 120 days, 90 days, less than about 60 days, less than about 30 days, less than about 15 days, less than about 10 days, or less than about 5 days, or less than about 3 days, or less than about 1 day. In some embodiments, the decrease of signs or symptoms occurs in less than 1 day, less than 1 week, less than 1 month, or in less than 1 year.

[0123] The terms “increased”, “increase”, “enhance”, or “activate” are all used herein to mean an increase by a statically significant amount. In some embodiments,PCT Patent Application Docket No.: 409948-508001 WO the terms “increased”, “increase”, “enhance”, or “activate” can mean an increase of at least 10% as compared to a reference level, for example an increase of at least about 20%, or at least about 30%, or at least about 40%, or at least about 50%, or at least about 60%, or at least about 70%, or at least about 80%, or at least about 90% or up to and including a 100% increase or any increase between 10-100% as compared to a reference level, or at least about a 2-fold, or at least about a 3-fold, or at least about a 4-fold, or at least about a 5-fold or at least about a 10-fold increase, or any increase between 2-fold and 10-fold or greater as compared to a reference level. In the context of a marker or symptom, a “increase” is a statistically significant increase in such level.

[0124] As used herein, an agent or a therapeutic agent provided to a subject and suspected to be or involved in a treatment can be a small molecule less than 1000 MW or a large molecule not less than 1000 MW including biologies, oligonucleotides, peptides, oligosaccharides, and larger molecules. Any of the therapeutic agents disclosed herein can be used as or in combination with small molecules and / or large molecules as discussed herein.

[0125] A subject can be one who has been previously diagnosed with or identified as suffering from or having a condition in need of treatment (e.g., a nerve compression, pain, weakness, numbness, tingling, a bone spur, arthritis, ora related disorder) or one or more complications related to such a condition, and optionally, but need not have already undergone treatment for a condition or one or more complications related to the condition. Alternatively, a subject can also be one who has not been previously diagnosed as having a condition in need of treatment or one or more complications related to such a condition. For example, a subject can be one who exhibits one or more risk factors for a condition, or one or more complications related to a condition or a subject who does not exhibit risk factors. A “subject in need” of treatment for a particular condition can be a subject having that condition, diagnosed as having that condition, suspected as having, or at risk of developing that condition. In another example, the subject has been brought into a treatment situation entirely without the subject’s knowledge and / or intent. For example, a subject can obviously be in need of treatment but not be responsive to a previous surgery, and as described herein the present methods and implants may save the subject’s life.PCT Patent Application Docket No.: 409948-508001 WO

[0126] As discussed above, unless otherwise defined herein, scientific and technical terms used in connection with the present application shall have the meanings that are commonly understood by those of ordinary skill in the art to which this disclosure belongs. It should be understood that this invention is not limited to the particular methodology, protocols, devices, implants, and reagents, etc., described herein and as such can vary. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention, which is defined solely by the claims. Definitions of common terms in immunology and molecular biology can be found in The Merck Manual of Diagnosis and Therapy;3The Encyclopedia of Molecular Cell Biology and Molecular Medicine;4Molecular Biology and Biotechnology: a Comprehensive Desk Reference;5Immunology;6Janeway's Immunobiology;7Lewin's Genes XI;8Molecular Cloning: A Laboratory Manual.;9Basic Methods in Molecular Biology;10Laboratory Methods in Enzymology;11Current Protocols in Molecular Biology (CPMB)12; Current Protocols in Protein Science (CPPS);13and Current Protocols in Immunology (CPI)14

[0127] Other terms are defined herein within the description of the various aspects of the invention. It is clearly contemplated herein that the technology can be used in surgeries in addition to ACDF, and the implants and techniques disclosed herein are not limited by the accurate discussion of applications in ACDF surgeries.

[0128] In the context of treatment and effective amounts as defined above, the term subject (which is to be read to include “individual”, “animal”, “patient” or “mammal” where context permits) defines any subject, particularly a mammalian subject, for whom treatment is indicated. Mammalian subjects include, but are not limited to, humans, domestic animals, farm animals, zoo animals, sport animals, pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, cows; primates such as apes, monkeys, orangutans, and chimpanzees; canids such as dogs and wolves; felids such as cats, lions, and tigers; equids such as horses, donkeys, and zebras; food animals such as cows, pigs, and sheep; ungulates such as deer and giraffes; and rodents such as mice, rats, hamsters and guinea pigs. In preferred embodiments, the subject is a human.

[0129] As used herein, the term “triplanar” as applied to the device of the invention means that the device has a substantially chamfered, C-shaped profile along most or all of its length, and generally along at least 60% of its length. DevicesPCT Patent Application Docket No.: 409948-508001 WO of the invention that include a lag window are generally monoplanar along a part of their length (generally along a central section) — these devices are suitable for reduction and fixation of clavicle fractures, especially comminuted clavicle fractures where the lag window allows a surgeon access the smaller fragments of bone and reduce and fix the fragments. Other embodiments of the invention are triplanar along all or substantially all of their length, for examples the devices for reduction and fixing ankle or elbow fractures.

[0130] As used herein, the term “C-shaped” profile” as applied to the triplanar plate of the invention means that a first plate is orthogonal or nearly orthogonal to a second plate along at least a part of its length with an intermediate, chamfer section extending between the first plate and the second plate. This profile is illustrated in FIG. 2. This provides structural rigidity and torsional stiffness to the plate, and also allows for fixing screws to be inserted in an orthogonal arrangement. It will be appreciated that the plates do not need to be exactly orthogonal provided that the angle between the plates serves to increase the stiffness of the device compared to monoplanar plates. All of these embodiments provide plates that are of increased torsional stiffness compared with monoplanar plates.

[0131] As used herein, the term “monoblock,” “unitary,” or “integrally formed,” as applied to a plate means that the plate is formed in one piece, generally by casting or molding. It is distinct from plates that are formed in multiple parts and assembled or contoured after formation.

[0132] Furthermore, reference in the specification to “an embodiment,” “one embodiment,” “various embodiments,” or any variant thereof means that a particular feature or aspect described in conjunction with the particular embodiment is included in at least one embodiment. Thus, the appearance of the phrases “in one embodiment,” “in another embodiment,” or variations thereof in various places throughout the specification are not necessarily all referring to its respective embodiment. .MULTIPLANAR BONE REDUCTION AND FIXATION PLATE

[0133] Now considering a surgery for a broken bone, the technology disclosed herein provides comfort and safety. The introduction of fixation plates with three planes of attachment (e.g., introduced in FIGS. 1A, 1B, 1C, and 2) offers significant advantages in orthopedic procedures. These plates are designed to conform to three distinct surfaces of a bone, providing enhanced stability and support. By engagingPCT Patent Application Docket No.: 409948-508001 WO multiple planes, these plates can better accommodate the natural contours and irregularities of the bone, improving alignment and reducing the risk of complications. This multi-surface engagement is particularly beneficial for bones with complex geometries, ensuring that the fixation device can provide consistent and reliable support. Additionally, the use of plates with three planes of attachment can lead to more efficient healing by minimizing the potential for misalignment and promoting optimal stabilization. This design allows for a more comprehensive approach to bone fixation, addressing the unique challenges presented by various anatomical structures and the forces they endure.

[0134] This disclosure provides a multiplanar bone reduction and fixation plate designed to aid in the stabilization and healing of fractured bones of an individual patient. Referring now to FIGs. 1A through 1C, plate 100 may include an elongated planar first flange 103 and a second flange 101 , both configured to overlay and substantially conform to the respective first and second surfaces of a bone, ensuring stabilization. The first bone surface may be a superior surface and the second surface may be an anterior or posterior surface. It will be appreciated by those skilled in the art with the benefit of this disclosure that the plate may be configured to overlay any adjacent bone surfaces: superior / anterior; superior / posterior; inferior / anterior; inferior / posterior as well as other orientations as required by bone surface and anatomical orientation.

[0135] The first flange, defining a first plane of attachment, may have a set of orthogonal holes 102 for receiving a first set of fasteners 107, which can secure the plate to a first surface of the bone. The first flange 103 may also include sliding screw holes 106, allowing for adjustable positioning of screws to enhance fixation. The second flange 101 , defining a second plane of attachment, may be configured with a second set of orthogonal holes 110 for receiving a second set of fasteners 109 for securing the second flange to a second surface of the bone. In some embodiments, second flange 101 is configured with a scalloped edge to optimize visibility of the underlying bone.

[0136] An elongated intermediate plate section 105, defining a third plane of attachment, can extend between the first and second flanges 103, 101, connecting them for structural integrity. This section 105 may be a chamfer between the first 103 and second 101 flanges providing a triplanar, C-shaped cross-section, and is formedPCT Patent Application Docket No.: 409948-508001 WO as a pre-contoured monoblock ( / .e., cast in one piece). The plate is preferably formed from stainless steel or titanium.

[0137] The second flange 101 may comprise first flange portion 101a and second flange portion 101b with a window 108 in between, providing access to a mid-portion M of the bone B to which the plate is affixed. Additionally, the first flange 103 may include angled screw holes 104 in the region over the window for receiving angled screws 113, further enhancing fixation capabilities. This configuration allows for a more secure attachment to the bone by providing an alternative trajectory for the screws, which can be beneficial in certain anatomical situations. The angled screw 113 placement is particularly advantageous in areas where traditional orthogonal screw placement may not provide sufficient stability. The inclusion of angled screw holes facilitates the distribution of mechanical forces across the bone, potentially reducing the risk of stress concentration and subsequent bone damage. This feature is integrated into the design of the plate to accommodate specific surgical requirements and anatomical variations, offering surgeons additional options for achieving optimal bone stabilization.

[0138] The plate can be versatile, applicable to various bones such as, without limitation, a clavicle, humerus, radius, rib, ulna, femur, tibia, fibula, metacarpal, patella and a metatarsal. In some designs, the first flange may have a counter-arc profile, which can adapt to specific anatomical conformations, offering enhanced access and fixation.

[0139] In some embodiments, FIG. 2 presents a section view along line A-A from FIG. 1B, illustrating the multiplanar bone reduction and fixation plate 100 overlaying a bone B. In this illustration, it can be seen that first flange 103 overlays and substantially conforms to the superior surface of bone B. Second flange 101 extends roughly perpendicular to first flange 103, overlaying and substantially conforming to the anterior surface of bone B. Chamfered intermediate section 105 extends between first and second flanges 103, 101. It will be appreciated multiplanar bone plate 100 may be configured to attach to a bone in any orientation.

[0140] It will further be appreciated that the triplanar profile of the plate allows the plate to be thinner along most, substantially all, or all of its surface, which is more comfortable for the patient, while allowing for greater bending and torsional stiffness, as the area moment of inertia is increased in both the coronal and axial planes. The plates typically comprise countersunk holes (although can also accommodatePCT Patent Application Docket No.: 409948-508001 WO traditional headed screws) for receipt of fixing screws, which are generally configured so that the heads of the screws do not extend proud of the surface of the plates, and generally are flush with the plate surface. There will be the option of locking or non-locking screws. It should be observed that the triplanar design facilitates a linked multi-axial fixation.

[0141] The multiplanar plate 100, by virtue of its C-shaped profile which extends along one or both ends of the plate, and in some cases, along the full length of the plate, allow for easier alignment of bone fragments with the plate, providing easier and more accurate bone reduction and fixation, while also providing a plate with better bending and torsional stiffness and having a lower profile. The embodiment with a C-shaped profile at the end sections only, provides an access window to the central, surface of the bone, allowing access to comminuted bone fragments and inhibiting devascularisation of the healing bone fragments. The loss of bending and torsional stiffness due to the lack of a C-shaped profile in the central section may be compensated for by increasing the thickness of the plate at the central section.

[0142] FIG. 3 depicts another version of a multiplanar plate 100’ for attachment to midshaft sections of bone B. FIG. 4 presents yet another version of plate 100” configured for overlaying and substantially conforming to one end of bone B. As an example, plate 100” may be configured to be attached to the distal end of a clavicle. In this case, first flange 103 is adapted with greater area to substantially completely overlay the superior surface of the distal end of the clavicle, a second flange 101 is contoured to substantially conform to the anterior surface.

[0143] As described above and shown in the associated drawings, the present invention comprises a multiplanar bone reduction and fixation plate. While particular embodiments have been described, it will be understood, however, that any invention appertaining to the apparatus / system / method described is not limited thereto, since modifications may be made by those skilled in the art, particularly in light of the foregoing teachings. It is, therefore, contemplated by the appended claims to cover any such modifications that incorporate those features or those improvements that embody the spirit and scope of the invention.

[0144] FIGS. 5A-5D illustrate a specific, non-limiting embodiment of the multiplanar bone reduction and fixation plate adapted for the left clavicle mid-shaft, with exemplary dimensions provided for illustrative purposes. The plate may bePCT Patent Application Docket No.: 409948-508001 WO fabricated from materials such as stainless-steel Type 316L, with a thickness of about 0.5 to about 5 mm, optionally about 1-2 mm, or optionally approximately 1.8 mm, but variations in size, material, and configuration are contemplated to suit different bones or patient anatomies. According to some aspects, the materials used can be wherein the plate includes a biocompatible material comprising stainless steel, a cobalt base alloy, a bio-ceramic, a titanium alloy, a pure titanium, a composite material, a non-resorbable polymers, a bioresorbable polymer, or a combination thereof. Portions of the implants can be resorbable, and portions can be non-resorbable. Any materials known in the art can be used.

[0145] In some embodiments, the materials are compatible with a bone adhesive, operative to adhere the plate to the vertebrae of the subject. In this example, no holes may be required for bone screws.

[0146] In some embodiments, FIG. 5A illustrates an isometric view of an exemplary multiplanar bone reduction and fixation plate configured for the left clavicle mid-shaft, where the overall contoured structure with first flange and split second flange engages multiple bone planes to distribute loads evenly, reducing torsional stresses during shoulder motion. According to some aspects, the plate's counter-arc profile conforms to anatomical curvatures, enabling stable fixation via orthogonal holes that accommodate screws for enhanced pull-out resistance in osteopenic bone. In this example, the isometric perspective highlights chamfered transitions that minimize soft tissue irritation, promoting faster healing through preserved vascularity.

[0147] In some embodiments, FIG. 5B depicts a top view of the plate, showcasing the elongated layout with hole placements that allow strategic screw distribution for interfragmentary compression across fractures. According to some aspects, the counter-arc profile facilitates alignment with the clavicle's natural bow, optimizing biomechanical stability under cyclic loads from daily activities. In this example, exemplary measurements guide manufacturing precision, ensuring the window between flange portions provides access for graft augmentation, fostering osteogenesis while the orthogonal holes support hybrid locking to adapt to varying bone densities.

[0148] In some embodiments, FIG. 5C presents a side view emphasizing multiplanar transitions between flanges and intermediate sections, which enhance rigidity against bending forces in load-bearing scenarios. According to some aspects,PCT Patent Application Docket No.: 409948-508001 WO the chamfered sections reduce stress concentrations, allowing the plate to conform without intraoperative bending, thus minimizing operative time and trauma. In this example, the profile illustrates thickness variations that balance strength with low-profile design, preventing prominence in superficial implants and supporting minimally invasive techniques for improved patient outcomes.

[0149] In some embodiments, referring to FIG. 5C, the circled 6 represents the overall height of the multiplanar bone reduction and fixation plate in the end view, specifically the vertical distance from the bottom surface of the second flange portion to the top surface of the first flange, measuring about 5 mm to about 30 mm, optionally about 10 mm to about 25 mm, optionally about 17 mm.

[0150] In some embodiments, FIG. 5D shows a cross-sectional view along section A-A, revealing internal hole diameters and plate thickness that ensure secure screw engagement for fixed-angle constructs. According to some aspects, the profiles optimize thread locking to resist micromotion, promoting primary bone healing in simple fractures. In this example, the section highlights material uniformity for fatigue resistance, enabling reliable performance under physiological stresses while accommodating biologies integration for accelerated recovery in complex cases.

[0151] FIGS. 6A-6D illustrate a non-limiting embodiment of a locking screw suitable for engagement with the orthogonal holes, angled screw holes, or sliding screw holes of the multiplanar bone reduction and fixation plate. The screw may have a diameter in a range from about 1 mm to about 4 mm, optionally about 1.5 mm to about 3 mm, or optionally approximately 2.4 mm, with a double-lead thread for secure bone purchase and a hexalobe head for torque application, available in lengths from about 5 mm to about 40 mm, optionally about 10 mm to about 30 mm as examples. Variations in size, thread design, and materials (such as stainless steel) are contemplated to accommodate different bone types and surgical needs.

[0152] In some embodiments, the detailed dimensions (e.g., 2.4mm diameter, double-lead threads, hexalobe head), material specs, thread pitches, and length variations in FIGS. 6A-6D are non-limiting examples. These figures add concrete, enabling details for the fasteners, for a complete "system" (plate + screws).

[0153] In FIG. 6A, in a non-limiting set of examples, for the locking screw 405, the circled 11 depicts the length of the unthreaded shank portion immediately below the screw head, measuring in a range from about 0.5 mm to about 3.0 mm,PCT Patent Application Docket No.: 409948-508001 WO optionally in a range from about 1.0 mm to about 2.5 mm, optionally about 1.8 mm. The circled 12 depicts the height or thickness of the screw head from the bearing surface to the top, measuring in a range from about 1.0 mm to about 3.5 mm, optionally in a range from about 1.5 mm to about 3.0 mm, optionally about 2.2 mm. The circled 13 depicts the variable length of the threaded portion of the screw (from the end of the shank to the tip, also known as the working length), denoted as "L" and measuring in a range from about 5 mm to about 50 mm, optionally in a range from about 10 mm to about 30 mm (tolerance shown on figure). The circled 14 depicts the lead of the double-lead thread on the screw body (the distance the screw advances per full rotation), measuring in a range from about 0.2 mm to about 1.5 mm, optionally in a range from about 0.4 mm to about 1.0 mm, optionally about 0.7 mm. The circled 15 depicts the minor radius of the screw tip fallout to the tip (the widest outer diameter of the radius), measuring in a range from about 1.0 mm to about 20.0 mm, optionally in a range from about 1.5 mm to about 15.0 mm, optionally about 13.11 mm. The circled 16 depicts the major radius and is depicted at about 13.46 mm. The circled 17 depicts the radius at the root of the screw thread (the curved transition between the thread flank and the minor diameter), measuring R in a range from about 0.1 mm to about 5.0 mm, optionally in a range from about 0.15 mm to about 3.0 mm, optionally about 0.25 mm.

[0154] In FIG. 6B, in a non-limiting set of examples, the circled 18 depicts the relief angle of the self-tapping flutes at the screw tip (three equally spaced flutes), measuring about 120° (120 degrees). The circled 19 is the axial length of the chamfer or lead-in at the screw tip, measuring in a range from about 0.01 mm to about 0.5 mm, optionally in a range from about 0.03 mm to about 0.3 mm, optionally about 0.08 mm

[0155] In FIG. 6C, in a non-limiting set of examples, for the locking screw 405, the circled 24 depicts the relief angle (or thread flank angle) at the screw tip in detail C, measuring about 20° (20 degrees). The circled 25 depicts the minor diameter of the screw thread in section B-B, measuring in a range from about 1.0 mm to about 4.0 mm, optionally in a range from about 1.0 mm to about 3.0 mm, optionally about 1.66 mm. The circled 26 depicts the major diameter of the screw thread in section B-B, measuring in a range from about 0.5 mm to about 3.5 mm, optionally in a range from about 1.0 mm to about 3.0 mm, optionally about 2.4 mm. The circled 27 depicts the pitch of the screw thread in section B-B, measuring in a range from about 0.2PCT Patent Application Docket No.: 409948-508001 WO mm to about 1.5 mm, optionally in a range from about 0.4 mm to about 1.0 mm, optionally about 0.7 mm.

[0156] In FIG. 6D, in a non-limiting set of examples, the circled 28 depicts the outer diameter of the hexalobe, measuring in a range from about 1.0 mm to about 8.0 mm, optionally in a range from about 1.0 mm to about 3.0 mm, optionally about 2.1 mm. The circled 29 depicts the axial length of the plateau around the hexalobe, measuring in a range from about 0.1 mm to about 1.5 mm, optionally in a range from about 0.1 mm to about 0.8 mm, optionally about 0.2 mm. The circled 30 depicts the fillet radius at the base of the screw head where it transitions to the undercut, measuring R in a range from about 0.2 mm to about 2.0 mm, optionally in a range from about 0.2 mm to about 1.5 mm, optionally about 0.37 mm. The circled 31 depicts the innermost hexalobe drive diameter in the screw head, measuring in a range from about 0.5 mm to about 3.0 mm, optionally in a range from about 0.8 mm to about 2.0 mm, optionally about 1.5 mm. The circled 32 depicts the tolerance on the minor diameter or a critical feature in the thread profile section, measuring in a range of + about 0.001 mm to about 0.1 mm and - about 0.004 mm, designated as datum A.

[0157] FIGS. 7A-7D illustrate a non-limiting embodiment of a cortical variable angle screw suitable for the angled screw holes of the multiplanar bone reduction and fixation plate. The screw may have a diameter of about 1 mm to about 4 mm, or approximately 2.0 mm, with a spherical head allowing for angulation from about 0-90 degrees or optionally up to about 15 degrees, self-tapping tip, and lengths from about 5 mm to about 40 mm, or optionally about 10 mm to 30 mm as examples. Variations in size, angulation range, and materials (such as stainless steel) are contemplated to suit different bone densities and surgical requirements.

[0158] In some embodiments, FIGS. 7A-7D show detailed engineering and / or manufacturing CAD drawings of a 2.0mm cortical variable angle screw designed for use with the multiplanar bone reduction and fixation plate system described herein. This screw is an ancillary component, specifically tailored for the "angled screw holes" (104) and "angled screws" (113) discussed above, allowing for variable angulation (optionally up to ±15° based on head design) to accommodate bone anatomy and improve fixation stability.

[0159] According to some aspects (non-limiting examples) in FIG. 7A (dimensions are shown in inches, with millimeter equivalents in brackets), for thePCT Patent Application Docket No.: 409948-508001 WO cortical variable angle screw 505, the circled 11 depicts the spacer thickness at the outer periphery of the screw head, measuring 0.005 ± 0.001 in [about 0.13 ± 0.03 mm]. The circled 12 depicts the spherical bearing radius on the underside of the screw head for variable-angle locking, measuring R 0.074 (+0.000 / -0.002) in [about 1.88 (+0.00 / -0.05) mm]. The circled 13 depicts a repeated dimension (three locations, 3X, e.g., for tapping) as shown, measuring 0.062 ± 0.001 in [about 1.57 ± 0.03 mm]. The circled 14 depicts a repeated radius dimension (three locations, 3X), measuring R 0.650 ± 0.001 in [about 16.51 ± 0.03 mm]. The circled 15 depicts a repeated linear dimension (three locations, 3X) measuring 0.666 ± 0.001 in [about 16.92 ± 0.03 mm]. The circled 16 depicts the overall working length “L”, with a tolerance of ± 0.01 in [± 0.25 mm], wherein (by way of non-limiting examples) L may be selected from 0.394-1.181 in [10-30 mm or about 5-50 mm] depending on the screw configuration / part number. The circled 17 depicts a fillet / runout radius at the indicated transition, measuring R 0.020 (+0.000 / -0.002) in [0.51 (+0.00 / -0.05) mm],

[0160] The circled 18 depicts the indicated axial length, measuring 0.078 ± 0.002 in [1.99 ± 0.05 mm], and the circled 19 depicts the indicated axial length, measuring 0.062 ± 0.002 in [about 1.57 ± 0.05 mm],

[0161] In another (non-limiting) example, in FIG. 7B, the circled 20 is the angular spacing of the self-tapping flutes at the screw tip (three equally spaced flutes), measuring three times 120 °. The circled 21 is the axial length of the flute or cutting edge at the screw tip, measuring about 0.01 mm to about 1 mm, optionally about 0.08 mm.

[0162] In yet another (non-limiting) example, in FIG. 7C, for the cortical variable angle screw 505, the circled 28 depicts the thread pitch (the axial distance between adjacent thread crests), measuring 0.024 ± 0.001 in [0.61 ± 0.03 mm]. The circled 29 depicts the minor diameter of the screw thread (at the thread roots), measuring 0.065 ± 0.001 in [1.65 ± 0.03 mm]. The circled 30 depicts the major diameter of the screw thread (at the thread crests), measuring 0.084 ± 0.001 in [2.13 ± 0.03 mm]. Examining FIG. 7D, in a non-limiting example, the circled 31 depicts a first (major) linear dimension of the T7 hexalobe drive recess (three places), measuring 3X 0.082 inches ± 0.001 inches [2.08±0.03 mm]. The circled 32 depicts a root / valley fillet radius of the hexalobe drive recess (six places), measuring 6X R0.008 inches +0.005 / -0.000. The circled 33 depicts a positional tolerance for the drive feature relative to datum A, measuring 0.004 inches relative to A. The circledPCT Patent Application Docket No.: 409948-508001 WO 34 depicts a second (minor) linear dimension of the T7 hexalobe drive recess (three places), measuring 3X 0.059 inches ± 0.001 inches [1.51 ±0.03 mm]. The circled 35 depicts a lobe radius of the hexalobe drive recess (six places), measuring 6X R0.015 inches +0.005 / -0.000 [0.37+0.13 / -0.00 mm],

[0163] In some other (inter-combinable) embodiments in FIG. 1A, multiplanar bone reduction and fixation plate 100 is contoured to seat on multiple adjacent surfaces of a target bone to achieve reduction and fixation with increased bending and torsional stiffness. First flange 103 is positioned along a first bone surface and is secured using a first set of orthogonal holes 102, which can receive bone fasteners oriented substantially orthogonal to first flange 103 to provide anchoring and compression. In some aspects, first flange 103 further includes sliding screw holes 106 that permit controlled translational adjustment of an inserted fastener along the elongated axis of each sliding screw hole 106, thereby enabling intraoperative compression, distraction, or fine reduction tuning before final tightening.

[0164] According to some aspects, second flange 101 extends from plate 100 such that second flange 101 overlays a second bone surface, thereby creating a multiplanar construct. Second flange 101 includes first flange portion 101a and second flange portion 101b separated by window 108. Window 108 can preserve periosteal blood supply, provide visualization of a fracture region, permit placement of graft or biologic adjuncts, and enable access for instrumentation while plate 100 remains provisionally or definitively fixed. Second flange 101 can include a second set of orthogonal holes 110 and, in addition or alternatively, third set of orthogonal screw holes 112 to deliver supplemental fixation into the second bone surface and to distribute loads across multiple screw trajectories.

[0165] In a non-limiting example, elongated intermediate plate section 105 extends between first flange 103 and second flange 101 and can function as a structural transition region, optionally chamfered or radiused, that increases section modulus while maintaining a low profile. Elongated intermediate plate section 105 may include first intermediate plate section 105a and second intermediate plate section 105b that respectively couple first flange 103 to first flange portion 101a and to second flange portion 101b, thereby maintaining rigidity around window 108. First flange 103 can further include angled screw holes 104 in a region adjacent window 108 to enable non-orthogonal screw trajectories for targeted purchase in available bone corridors, including fixed-angle and variable-angle options.PCT Patent Application Docket No.: 409948-508001 WO

[0166] In some other (inter-combinable) embodiments in FIG. 1B, multiplanar bone reduction and fixation plate 100 is positioned along bone B to span a fracture site, with second flange 101 conforming to an anterior or inferior surface and first flange 103 aligning with a superior surface, thereby establishing multiplanar engagement that enhances torsional and bending stability under physiological loads. According to some aspects, window 108 facilitates direct access to mid-portion of the bone M, enabling precise fracture reduction and application of interfragmentary compression prior to final fixation, which promotes primary bone healing through minimized micromotion at the fracture interface. In this example, line A-A 120 denotes a cross-sectional plane through the assembly, illustrating how the intermediate section between flanges distributes axial compressive forces evenly across bone B, reducing stress concentrations that could lead to implant failure or nonunion. In a non-limiting example, the configuration of multiplanar bone reduction and fixation plate 100 on bone B allows for variable screw angulation through associated holes, accommodating diverse fracture patterns such as comminuted or segmental breaks, while providing superior resistance to multi-directional stresses from shoulder girdle movements. In some embodiments, this setup supports early mobilization by maintaining construct rigidity, with biomechanical advantages including increased stiffness in cantilever bending compared to single-plane alternatives, thus mitigating risks of delayed union in osteopenic bone. According to some aspects, window 108 over mid-portion of the bone M permits augmentation with bone grafts or biologies, fostering osteogenesis through preserved periosteal blood supply. In this example, line A-A 120 highlights the chamfered transitions that minimize soft tissue irritation, optimizing healing dynamics in load-bearing scenarios.

[0167] In some other (inter-combinable) embodiments in FIG. 1C, multiplanar bone reduction and fixation plate 100 is secured to a fractured bone via first set of fasteners 107, second set of fasteners 109, and third set of fasteners 111, with angled screws 113 inserted through angled screw holes 104 to achieve polyaxial fixation that enhances construct stability in comminuted or oblique fracture patterns. According to some aspects, second flange 101 spans the inferior bone surface, while first flange 103 overlays the superior aspect, connected by first intermediate plate section 105a and second intermediate plate section 105b, thereby distributing shear and torsional loads across multiple planes to mitigate implant loosening under cyclic loading. In this example, sliding screw holes 106 accommodate first set of fastenersPCT Patent Application Docket No.: 409948-508001 WO 107 in a dynamic compression mode, facilitating controlled axial micromotion at the fracture site to stimulate callus formation through secondary bone healing mechanisms. In a non-limiting example, window 108 provides unobstructed access for graft placement or lag screw augmentation, with second set of fasteners 109 engaging cortical bone to maintain reduction integrity during early rehabilitation phases. In some embodiments, angled screws 113 diverge at variable trajectories through angled screw holes 104, optimizing purchase in denser metaphyseal regions and reducing stress risers that could propagate secondary fractures. According to some aspects, third set of fasteners 111 locks into distal segments via second intermediate plate section 105b, promoting load-sharing fixation that preserves periosteal blood supply and accelerates osteogenesis in osteoporotic conditions. In this example, the assembly of multiplanar bone reduction and fixation plate 100 with first set of fasteners 107, second set of fasteners 109, and third set of fasteners 111 creates a rigid scaffold, resisting multi-axial forces from muscular attachments while allowing biologic integration through surface porosity options. In a non-limiting example, first intermediate plate section 105a and second intermediate plate section 105b incorporate chamfered edges to minimize soft tissue irritation, enabling application in minimally invasive approaches for reduced operative morbidity.

[0168] In some other embodiments in FIG. 2, is illustrated a section view along line A-A showing multiplanar bone reduction and fixation plate 100 seated on bone B with three distinct planes of attachment. In this example, first flange 103 defines 1st plane 205 and is contoured to overlay a superior surface of bone B, thereby resisting bending moments generated during physiologic loading. Second flange 101 defines 2nd plane 210 and extends generally transverse to first flange 103 such that second flange 101 overlays an anterior surface of bone B, thereby increasing torsional stiffness by engaging an additional cortical surface and reducing the likelihood of plate lift-off. Elongated intermediate plate section 105 defines 3rd plane 215 and extends between first flange 103 and second flange 101 , forming a triplanar, C-shaped cross-sectional profile that increases the area moment of inertia relative to a monoplanar plate configuration, thereby improving resistance to combined torsion, bending, and shear.

[0169] According to some aspects, during fixation and healing, plate 100 distributes load from bone B across 1st plane 205, 2nd plane 210, and 3rd plane 215 to stabilize fracture fragments while maintaining alignment. In a non-limitingPCT Patent Application Docket No.: 409948-508001 WO example, elongated intermediate plate section 105 acts as a structural transition that reduces localized stress concentrations at the junction between first flange 103 and second flange 101 , optionally improving fatigue performance under cyclic loading. In some embodiments, plate 100 is fabricated from stainless steel, titanium, or another biocompatible alloy, optionally including surface texturing, porous regions, or bioactive coatings to promote osteointegration at interfaces adjacent to bone B while preserving the intended multiplanar conformity along 1st plane 205, 2nd plane 210, and 3rd plane 215.

[0170] In some other (inter-combinable) embodiments in FIG. 3, another version of a multiplanar plate 100' is applied to bone B in a continuous configuration without a central window, providing uniform spanning across transverse or spiral fractures to distribute compressive forces evenly and promote primary healing through absolute stability. According to some aspects, multiplanar plate 100' conforms to the anatomical contours of bone B, with its elongated structure aligning along the diaphyseal axis to resist bending moments from muscular pull, thereby reducing the risk of implant migration in high-stress environments such as humeral orfemoral applications. In this example, the plate's triplanar design engages multiple bone surfaces on bone B, enhancing torsional rigidity and allowing for load-sharing fixation that stimulates osteoblastic activity while minimizing stress shielding effects. In a non-limiting example, another version of a multiplanar plate 100' facilitates hybrid fixation on bone B, incorporating locking and non-locking screws to adapt to varying bone densities, thus optimizing pull-out strength in osteoporotic conditions through strategic screw convergence. In some embodiments, the contoured profile of multiplanar plate 100' matches the natural curvature of bone B, enabling minimally invasive insertion techniques that preserve periosteal vascularity and accelerate fracture consolidation via enhanced biologic response. According to some aspects, this variant supports dynamic loading on bone B, where the plate's material properties, such as titanium or stainless-steel alloys, ensure fatigue resistance under cyclic stresses from daily activities. In this example, another version of a multiplanar plate 100' allows for augmentation with biologies along bone B, fostering endochondral ossification in comminuted segments by maintaining alignment without excessive rigidity. In a non-limiting example, the assembly on bone B incorporates variable angle capabilities, permitting screw trajectories that avoid neurovascular bundles while maximizing cortical purchase for superior biomechanical outcomes.PCT Patent Application Docket No.: 409948-508001 WO

[0171] In some other (inter-combinable) embodiments in FIG.4, yet another version of a multiplanar plate 100" is configured for extended fixation along long bones, with distal end 305 tapering to facilitate submuscular insertion and minimize soft tissue disruption in diaphyseal-metaphyseal transition zones. According to some aspects, yet another version of a multiplanar plate 100" spans complex fractures by aligning distal end 305 with the metaphyseal flare, enabling hybrid locking to distribute axial loads and promote callus formation through controlled micromotion. In this example, distal end 305 incorporates variable angle holes for polyaxial screw placement, optimizing cortical purchase in osteoporotic bone while resisting varus collapse in unstable patterns. In a non-limiting example, yet another version of a multiplanar plate 100" supports load-bearing applications, where distal end 305 enhances torsional stability by engaging wider bone segments, thus reducing implant stress under cyclic fatigue from ambulation. In some embodiments, distal end 305 allows for augmentation with cerclage wires or cables, fostering biomechanical synergy in comminuted fractures to accelerate endochondral ossification. According to some aspects, yet another version of a multiplanar plate 100" adapts to anatomical variations via precontoured curves at distal end 305, minimizing bending stresses and preserving periosteal vascularity for enhanced healing dynamics. In this example, distal end 305 facilitates minimally invasive techniques, with its low-profile design reducing prominence and irritation in superficial placements. In a non-limiting example, yet another version of a multiplanar plate 100" integrates with biologies at distal end 305, promoting osteoconduction in nonunions through strategic porosity options for sustained release of growth factors.

[0172] In some other (inter-combinable) embodiments, FIG. 5A illustrates a multiplanar bone reduction and fixation plate configured for a left clavicle mid-shaft, with an underside contour that can be pre-shaped to substantially conform to an anatomic surface and reduce the need for intraoperative bending. According to some aspects, the elongated plate body includes multiple apertures and elongated openings distributed along the length to accept fixation fasteners while preserving access to the underlying fracture site for reduction, graft placement, and visualization. In this example, local thickening and smooth peripheral transitions can increase bending and torsional stiffness while maintaining a low-profile outer surface to reduce soft-tissue irritation. In non-limiting examples, the plate can comprise titanium alloy, stainless steel, cobalt-chromium alloy, polymer composites, orPCT Patent Application Docket No.: 409948-508001 WO combinations thereof, optionally with porous, ceramic, or antimicrobial surface treatments to promote osteointegration and infection resistance.

[0173] In some other (inter-combinable) embodiments, FIG. 5B depicts the superior-facing surface of the plate of FIG. 5A and highlights an elongated structure having a counter-arc profile adapted to the S-shaped curvature of a clavicle midshaft. In some embodiments, the hole pattern and the elongated openings are arranged to support multiple fixation strategies, including compression across a fracture line, neutralization after lag fixation, and bridging fixation across comminuted regions. In this example, selected holes can be configured as locking interfaces, variable-angle interfaces, or dynamic slots to permit controlled translation during tightening for intraoperative reduction. In non-limiting examples, the superior surface can include chamfers, countersinks, radiopaque markings, and edge rounding to guide implantation and reduce stress concentrations.

[0174] In some other (inter-combinable) embodiments, FIG. 5C provides a side view showing multiplanar transitions between end regions and intermediate regions, which can be configured to engage different faces of a clavicle and thereby increase structural rigidity by elevating the area moment of inertia. According to some aspects, circled 6 represents an overall plate height in the end view, defined as a vertical distance between a lower flange region and an upper flange region, which can be selected to match patient anatomy and to balance low profile with construct stiffness. In a non-limiting example, the multiplanar transition can further provide clearance for periosteum and soft tissues while maintaining a stable mechanical envelope that resists torsion and bending during shoulder loading.

[0175] In some other (inter-combinable) embodiments, FIG. 5D shows a cross-sectional view along section A-A through the plate of FIG. 5A, highlighting plate thickness, internal profiles, and hole geometry as non-limiting examples.According to some aspects, the section illustrates a structural wall thickness that can be maintained substantially uniform or locally increased around hole regions to reduce deformation and improve screw purchase, while preserving a smooth tissuefacing contour. In this example, the cross-section further demonstrates how countersunk or tapered features can support flush or recessed screw heads, reducing prominence. In non-limiting examples, the cross-sectional architecture can include ribs, fillets, and gradual curvature transitions to mitigate stress risers and to improve fatigue life under cyclic loading.PCT Patent Application Docket No.: 409948-508001 WO

[0176] In some other (inter-combinable) embodiments in FIG. 6A, locking screw 405 engages orthogonal holes in a bone plate through its double-lead thread, providing rapid advancement and secure cortical purchase to enhance fixation stability in osteopenic bone. According to some aspects, locking screw 405 incorporates a hexalobe drive for high-torque transmission, minimizing cam-out risks during insertion into dense metaphyseal regions. In this example, locking screw 405 features a self-tapping tip with flutes, enabling direct penetration without predrilling to preserve bone stock and reduce operative time. In a non-limiting example, locking screw 405 supports variable lengths for bicortical fixation, promoting load-sharing constructs that stimulate secondary healing via controlled micromotion.

[0177] In some other (inter-combinable) embodiments in FIG. 6B, locking screw 405 utilizes a chamfered lead-in at the tip to facilitate smooth entry into cortical layers, reducing insertion torque and thermal necrosis. According to some aspects, locking screw 405 includes relief angles on flutes for efficient chip evacuation, optimizing performance in hard bone types. In this example, locking screw 405 employs equally spaced flutes to balance cutting efficiency, preventing eccentric loading during self-tapping. In a non-limiting example, locking screw 405 allows integration with biologies, where flute geometry aids in debris clearance to maintain clean interfaces for osseointegration.

[0178] In some other (inter-combinable) embodiments in FIG. 6C, locking screw 405 exhibits a thread profile with major and minor diameters calibrated for maximal pull-out resistance in cancellous bone. According to some aspects, locking screw 405 has a pitch designed for progressive compression, fostering interfragmentary stability in comminuted fractures. In this example, locking screw 405 ensures uniform stress distribution through its sectioned view, mitigating fatigue failure under cyclic loads. In a non-limiting example, locking screw 405 supports hybrid fixation modes, where thread geometry adapts to varying bone densities for enhanced biomechanical outcomes.

[0179] In some other (inter-combinable) embodiments in FIG. 6D, locking screw 405 features an undercut beneath the head for flush seating against plates, preventing soft tissue irritation in superficial applications. According to some aspects, locking screw 405 includes a fillet radius at transitions to reduce stress concentrations, improving longevity in load-bearing scenarios. In this example, locking screw 405 employs a hexalobe recess depth for secure driver engagement,PCT Patent Application Docket No.: 409948-508001 WO enabling precise torque control. In a non-limiting example, locking screw 405 integrates datum tolerances for manufacturing precision, ensuring consistent locking mechanisms across variable surgical conditions.

[0180] In some other (inter-combinable) embodiments in FIG. 7A, cortical variable angle screw 505 features a spherical head for polyaxial locking within plate holes, allowing angulation up to 15 degrees to adapt to irregular bone surfaces and optimize purchase in metaphyseal zones. According to some aspects, cortical variable angle screw 505 incorporates a self-tapping tip with flutes spaced at 120 degrees, facilitating insertion without predrilling to preserve bone integrity in fragile cortices. In this example, cortical variable angle screw 505 employs a thread pitch calibrated for cortical engagement, promoting compression in lag mode for stable fragment approximation. In a non-limiting example, cortical variable angle screw 505 supports variable lengths for bicortical fixation, enhancing resistance to pull-out forces in osteoporotic conditions.

[0181] In some other (inter-combinable) embodiments in FIG. 7B, cortical variable angle screw 505 utilizes flute relief angles to evacuate bone debris efficiently, reducing thermal necrosis during high-speed insertion in dense bone. According to some aspects, cortical variable angle screw 505 includes a chamfered lead-in for smooth entry, minimizing skiving and ensuring precise trajectory in minimally invasive approaches. In this example, cortical variable angle screw 505 balances cutting edge sharpness with structural durability, enabling reliable selftapping in varying bone qualities. In a non-limiting example, cortical variable angle screw 505 allows integration with biologies, where tip geometry clears pathways for graft delivery to accelerate osteoconduction.

[0182] In some other (inter-combinable) embodiments in FIG. 7C, cortical variable angle screw 505 exhibits a thread profile with major and minor diameters designed for maximal shear strength, supporting load-bearing in dynamic environments. According to some aspects, cortical variable angle screw 505 has a pitch that enables progressive bone engagement, fostering interfragmentary stability in oblique fractures. In this example, cortical variable angle screw 505 ensures even stress distribution through its cross-section, mitigating fatigue under cyclic loads from ambulation. In a non-limiting example, cortical variable angle screw 505 adapts to hybrid constructs, where thread dimensions accommodate both locking and compression modes for versatile applications.PCT Patent Application Docket No.: 409948-508001 WO

[0183] In some other (inter-combinable) embodiments in FIG. 7D, cortical variable angle screw 505 features a hexalobe recess in the head for superior torque transfer, preventing stripping during final tightening in deep tissues. According to some aspects, cortical variable angle screw 505 includes an undercut fillet radius to reduce stress risers, improving longevity in high-stress implants. In this example, cortical variable angle screw 505 employs a spherical underside for variable locking, allowing custom angulation to bypass neurovascular structures. In a non-limiting example, cortical variable angle screw 505 supports low-profile seating, minimizing prominence and irritation in superficial bone fixations.

[0184] In some embodiments, the screws disclosed in FIGS. 6A-6D and FIGS. 7A-7D are provided as ancillary fasteners for a bone fixation system and are configured to be selectively used with any multiplanar bone reduction and fixation plate embodiment, including plate embodiments adapted for different bones, contours, and hole patterns. In a non-limiting example, a locking screw 405 includes a threaded shaft and a head having a hexalobe drive recess, and is suitable for engagement with orthogonal holes, angled screw holes, or sliding screw holes to provide fixed-angle stability, compression, and resistance to loosening under cyclic loading. In some embodiments, a cortical variable angle screw 113 includes a spherical head that permits polyaxial placement to target optimal bone stock and to accommodate patient-specific anatomy and bone corridors while maintaining a locking interface with a corresponding plate hole. According to some aspects, either screw type can include self-tapping tip features with flutes to facilitate insertion, and either screw type can be provided in a range of lengths, pitches, and diameters to support cortical bone, cancellous bone, osteoporotic bone, or revision conditions, optionally using stainless steel Type 316L, titanium, or other biocompatible materials.

[0185] When (and while) discussing and / or contemplating the invention disclosed herein, greater numbers of details were conceived of and written down (non-limiting examples reproduced below), and these can be inter-combined with any feature, example, aspect, embodiment, or disclosure herein. In an example list of details (additional embodiments) shown below, further details for inter-combination herein are written down and disclosed:

[0186] Detail 1: A multiplanar bone reduction and fixation plate (100) comprising: an elongated planar first flange (103) contoured to overlay and substantially conform to a first surface of a bone (B); an elongated second flangePCT Patent Application Docket No.: 409948-508001 WO (101) configured to overlay and substantially conform to a second surface of the bone (B); and an elongated intermediate plate section (105) extending between the first flange (103) and the second flange (101 ), wherein the first flange (103), the second flange (101), and the intermediate plate section (105) are each configured with respective sets of fastener holes (102, 110, 112) for receiving fasteners (107, 109, 111) to affix the plate (100) to the bone (B), and wherein the plate (100) defines three planes of attachment (205, 210, 215).

[0187] Detail 2: The multiplanar bone reduction and fixation plate (100) of detail 1, wherein the second flange (101) comprises first and second flange portions (101a, 101 b) with a window (108) therebetween for allowing access to a mid-portion (M) of the bone (B).

[0188] Detail 3: The multiplanar bone reduction and fixation plate (100) of detail 2, wherein the intermediate plate section (105) comprises first and second intermediate plate sections (105a, 105b), the first intermediate plate section (105a) extending between the first flange (103) and the first flange portion (101a), and the second intermediate plate section (105b) extending between the first flange (103) and the second flange portion (101b).

[0189] Detail 4: The multiplanar bone reduction and fixation plate (100) of detail 3, wherein the first flange (103) includes first and second angled screw holes (104) defined through a surface thereof in a region over the window (108).

[0190] Detail 5: The multiplanar bone reduction and fixation plate (100) of detail 4, wherein the angled screw holes (104) are configured to receive angled screws (113) at an angulation in a range from about 0 degrees to about 90 degrees, optionally about 0 degrees to about 30 degrees, optionally in a range from about 7.5 degrees to about 22.5 degrees, thereby enabling targeted bicortical purchase in the mid-portion (M) while avoiding neurovascular structures.

[0191] Detail 6: The multiplanar bone reduction and fixation plate (100) of detail 3, wherein the first flange (103) includes first and second sliding screw holes (106) defined through a surface thereof.

[0192] Detail 7: The multiplanar bone reduction and fixation plate (100) of detail 6, wherein the sliding screw holes (106) have an elongated shape allowing for dynamic compression or distraction adjustment in a range from about 0.5 mm to about 5 mm, optionally in a range from about 1.25 mm to about 3.75 mm, to promote interfragmentary compression and enhance callus formation.PCT Patent Application Docket No.: 409948-508001 WO

[0193] Detail 8: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the first flange (103) comprises a counter-arc profile configured to conform to the natural S-shaped curvature of a clavicle midshaft.

[0194] Detail 9: The multiplanar bone reduction and fixation plate (100) of detail 8, wherein the counter-arc profile has a radius in a range from about 10 mm to about 100 mm, optionally in a range from about 25 mm to about 75 mm, thereby minimizing soft tissue irritation and improving long-term patient comfort.

[0195] Detail 10: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is contoured for a bone (B) selected from the group consisting of a clavicle, a humerus, a radius, an ulna, a femur, a tibia, a fibula, a rib, a metacarpal, a patella, and a metatarsal.

[0196] Detail 11 : The multiplanar bone reduction and fixation plate (100) of detail 10, wherein the plate (100) is specifically contoured for a clavicle midshaft with an overall length in a range from about 50 mm to about 200 mm, optionally in a range from about 75 mm to about 150 mm, and an overall thickness in a range from about 0.5 mm to about 5 mm, optionally in a range from about 1.25 mm to about 3.75 mm.

[0197] Detail 12: The multiplanar bone reduction and fixation plate (100) of detail 11 , wherein the plate (100) is provided in left-sided and right-sided configurations to accommodate the asymmetric anatomy of the left and right clavicles.

[0198] Detail 13: The multiplanar bone reduction and fixation plate (100) of detail 1, wherein the intermediate plate section (105) includes at least one chamfered section to facilitate smooth transition between planes and reduce stress risers.

[0199] Detail 14: The multiplanar bone reduction and fixation plate (100) of detail 13, wherein the chamfered section has a chamfer angle in a range from about 20 degrees to about 80 degrees, optionally in a range from about 30 degrees to about 60 degrees, thereby improving plate-to-bone conformity and minimizing periosteal disruption.

[0200] Detail 15: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is fabricated from stainless steel Type 316L or titanium alloy to provide high fatigue resistance and biocompatibility.PCT Patent Application Docket No.: 409948-508001 WO

[0201] Detail 16: The multiplanar bone reduction and fixation plate (100) of detail 1, wherein the plate (100) has a low-profile design with a maximum thickness in a range from about 1.5 mm to about 3.0 mm, optionally in a range from about 1.8 mm to about 2.5 mm, to reduce soft tissue irritation and improve postoperative cosmesis.

[0202] Detail 17: The multiplanar bone reduction and fixation plate (100) of detail 2, wherein the window (108) has a width in a range from about 5 mm to about 50 mm, optionally in a range from about 12.5 mm to about 37.5 mm, enabling intraoperative visualization, debridement, and placement of autologous bone graft or synthetic substitutes.

[0203] Detail 18: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the fastener holes (102, 110, 112) comprise a combination of threaded locking holes and non-threaded compression holes to allow hybrid fixation techniques.

[0204] Detail 19: The multiplanar bone reduction and fixation plate (100) of detail 18, wherein the threaded locking holes are configured for fixed-angle or variable-angle screws to provide angular stability and prevent screw toggle.

[0205] Detail 20: The multiplanar bone reduction and fixation plate (100) of detail 1, wherein the plate (100) includes staggered hole patterns to distribute load and reduce the risk of bone stress shielding.

[0206] Detail 21 : The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the three planes of attachment (205, 210, 215) provide enhanced rotational stability compared to conventional single-plane plates, particularly in comminuted midshaft clavicle fractures.

[0207] Detail 22: The multiplanar bone reduction and fixation plate (100) of detail 1, wherein the plate (100) is electropolished to minimize bacterial adhesion and reduce the risk of postoperative infection.

[0208] Detail 23: The multiplanar bone reduction and fixation plate (100) of detail 1, wherein the plate (100) is configured to allow intraoperative contouring to accommodate patient-specific anatomy.

[0209] Detail 24: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the fastener holes (102, 110, 112) are countersunk to provide flush screw seating and minimize soft tissue impingement.PCT Patent Application Docket No.: 409948-508001 WO

[0210] Detail 25: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is provided in a kit with multiple sizes and configurations for intraoperative selection.

[0211] Detail 26: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is designed to permit placement of bone graft or bone morphogenetic protein through the window (108) to enhance biological healing in atrophic non-unions.

[0212] Detail 27: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the first flange (103) and second flange (101 ) are configured to provide superior, inferior, and anterior fixation surfaces for the clavicle, thereby creating a three-dimensional construct that resists torsional forces.

[0213] Detail 28: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) includes at least 6 to 12 fastener holes per flange, optionally 8 to 10 holes, to distribute fixation points along the fracture length.

[0214] Detail 29: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured for use in displaced midshaft clavicle fractures with shortening greater than 20 mm, providing anatomical restoration and early mobilization.

[0215] Detail 30: The multiplanar bone reduction and fixation plate (100) of detail 1, wherein the plate (100) is configured to minimize plate prominence to reduce the need for secondary removal surgery.

[0216] Detail 31: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to allow for hybrid fixation with both locking and non-locking screws to optimize stability in osteoporotic bone.

[0217] Detail 32: The multiplanar bone reduction and fixation plate (100) of detail 1, wherein the plate (100) is configured to permit dynamic compression across the fracture site through sliding screw holes (106) to promote primary bone healing.

[0218] Detail 33: The multiplanar bone reduction and fixation plate (100) of detail 1, wherein the plate (100) is configured to provide multiplanar fixation that enhances biomechanical stability in complex fractures with butterfly fragments.

[0219] Detail 34: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to allow for screw placement in the mid-portion (M) through angled screw holes (104) to achieve bicortical purchase in the densest bone stock.PCT Patent Application Docket No.: 409948-508001 WO

[0220] Detail 35: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to reduce the risk of refracture by providing a protective bridge over the fracture site with distributed fixation.

[0221] Detail 36: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to allow for intraoperative adjustment of reduction using the window (108) for direct visualization and manipulation.

[0222] Detail 37: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to provide superior resistance to bending and torsional forces compared to conventional single-plane plates.

[0223] Detail 38: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to allow for use in both acute fractures and revision surgery for non-unions or malunions.

[0224] Detail 39: The multiplanar bone reduction and fixation plate (100) of detail 1, wherein the plate (100) is configured to minimize disruption of the periosteal blood supply, promoting faster union.

[0225] Detail 40: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to allow for placement of additional fixation devices through the window (108), such as cerclage wires or additional miniplates.

[0226] Detail 41 : The multiplanar bone reduction and fixation plate (100) of detail 1, wherein the plate (100) is configured to provide enhanced stability in patients with poor bone quality by allowing variable-angle screw placement.

[0227] Detail 42: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to allow for use with bone graft material to fill the window (108) and promote osseous integration.

[0228] Detail 43: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to permit screw placement in the intermediate plate section (105) to secure butterfly fragments or comminuted segments.

[0229] Detail 44: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to provide a low-profile construct that reduces the incidence of implant-related discomfort.PCT Patent Application Docket No.: 409948-508001 WO

[0230] Detail 45: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to allow for use in pediatric or adolescent patients with appropriate size scaling.

[0231] Detail 46: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to provide fixation in the superior, inferior, and anterior planes of the clavicle to resist superior displacement forces.

[0232] Detail 47: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to allow for intraoperative imaging through the window (108) to confirm reduction and screw placement.

[0233] Detail 48: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to provide enhanced stability for early range of motion and rehabilitation.

[0234] Detail 49: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to allow for use in combination with external immobilization for complex fracture patterns.

[0235] Detail 50: The multiplanar bone reduction and fixation plate (100) of detail 1 , wherein the plate (100) is configured to minimize the risk of screw pull-out in osteoporotic bone through multiplanar fixation.

[0236] Detail 51 : A bone fixation system comprising: the multiplanar bone reduction and fixation plate (100) of detail 1; and a plurality of fasteners (107, 109, 111, 113) configured for insertion into the fastener holes (102, 110, 112) and angled screw holes (104).

[0237] Detail 52: The bone fixation system of detail 51 , wherein at least one fastener is a locking screw having a diameter in a range from about 1 mm to about 5 mm, optionally in a range from about 1.75 mm to about 3.75 mm.

[0238] Detail 53: The bone fixation system of detail 52, wherein the locking screw has a double-lead thread with a lead in a range from about 0.2 mm to about 1.5 mm, optionally in a range from about 0.35 mm to about 1 mm, to allow faster insertion and improved bone purchase.

[0239] Detail 54: The bone fixation system of detail 51 , wherein at least one fastener is a cortical variable angle screw (113) allowing for angulation up to about 15 degrees in any direction.

[0240] Detail 55: The bone fixation system of detail 54, wherein the cortical variable angle screw has a spherical head with a radius in a range from about 0.5PCT Patent Application Docket No.: 409948-508001 WO mm to about 3 mm, optionally in a range from about 0.875 mm to about 2 mm, to enable polyaxial fixation and avoid critical structures.

[0241] Detail 56: The bone fixation system of detail 51 , wherein the fasteners include self-tapping tips with flutes spaced at about 120 degrees to facilitate insertion without predrilling in cortical bone.

[0242] Detail 57: The bone fixation system of detail 51 , wherein the fasteners have hexalobe drive recesses with a depth in a range from about 0.5 mm to about 3 mm, optionally in a range from about 0.875 mm to about 2 mm, to provide superior torque transmission and reduce cam-out.

[0243] Detail 58: The bone fixation system of detail 51 , wherein the fasteners have lengths in a range from about 5 mm to about 50 mm, optionally in a range from about 12.5 mm to about 37.5 mm, to accommodate varying bone thickness.

[0244] Detail 59: The bone fixation system of detail 51 , wherein the fasteners are fabricated from stainless steel Type 316L or titanium alloy for biocompatibility and corrosion resistance.

[0245] Detail 60: The bone fixation system of detail 51 , wherein the fasteners include a combination of locking and non-locking screws to allow hybrid fixation techniques for optimal stability and compression.

[0246] Detail 61 : The bone fixation system of detail 51 , wherein the fasteners are coated with hydroxyapatite or other osteoconductive materials to enhance osseointegration.

[0247] Detail 62: The bone fixation system of detail 51 , wherein the fasteners are configured for use in both cortical and cancellous bone, with appropriate thread pitch for each.

[0248] Detail 63: The bone fixation system of detail 51 , wherein the fasteners include self-drilling tips to reduce operative time in dense cortical bone.

[0249] Detail 64: The bone fixation system of detail 51 , wherein the fasteners are provided in a kit with varying diameters and lengths for intraoperative selection.

[0250] Detail 65: The bone fixation system of detail 51 , wherein the fasteners are configured to provide compression across the fracture site when used in sliding screw holes (106).

[0251] Detail 66: The bone fixation system of detail 51 , wherein the fasteners are configured to allow for bicortical purchase in the mid-portion (M) through angled screw holes (104).PCT Patent Application Docket No.: 409948-508001 WO

[0252] Detail 67: The bone fixation system of detail 51 , wherein the fasteners are configured to provide angular stability in osteoporotic bone through locking mechanisms.

[0253] Detail 68: The bone fixation system of detail 51 , wherein the fasteners are configured to allow for polyaxial placement to target optimal bone stock.

[0254] Detail 69: The bone fixation system of detail 51 , wherein the fasteners are configured to minimize soft tissue irritation through low-profile heads.

[0255] Detail 70: The bone fixation system of detail 51 , wherein the fasteners are configured to allow for use in revision surgery by providing reliable purchase in previously drilled bone.

[0256] Detail 71 : A locking screw for use in a bone fixation system, comprising: a threaded shaft with a double-lead thread; a head with a hexalobe drive recess; and a self-tapping tip with flutes.

[0257] Detail 72: The locking screw of detail 71 , wherein the threaded shaft has a major diameter in a range from about 1 mm to about 5 mm, optionally in a range from about 1.75 mm to about 3.75 mm.

[0258] Detail 73: The locking screw of detail 71 , wherein the double-lead thread has a pitch in a range from about 0.2 mm to about 1.5 mm, optionally in a range from about 0.35 mm to about 1 mm.

[0259] Detail 74: The locking screw of detail 71 , wherein the self-tapping tip has a relief angle of about 20 degrees to facilitate insertion in cortical bone.

[0260] Detail 75: The locking screw of detail 71 , wherein the hexalobe drive recess has an inner diameter in a range from about 0.5 mm to about 3 mm, optionally in a range from about 0.875 mm to about 2 mm.

[0261] Detail 76: The locking screw of detail 71 , having an overall length in a range from about 5 mm to about 50 mm, optionally in a range from about 12.5 mm to about 37.5 mm.

[0262] Detail 77: The locking screw of detail 71 , further comprising an undercut beneath the head with an axial length in a range from about 0.1 mm to about 1.5 mm, optionally in a range from about 0.275 mm to about 1 mm.

[0263] Detail 78: The locking screw of detail 71 , wherein the threaded shaft includes a locking mechanism for engagement with threaded holes in the plate (100).PCT Patent Application Docket No.: 409948-508001 WO

[0264] Detail 79: The locking screw of detail 71 , wherein the screw is configured for use in cortical bone with a thread design that provides enhanced purchase in dense bone.

[0265] Detail 80: The locking screw of detail 71 , wherein the screw is configured to provide compression when used in sliding screw holes (106).

[0266] Detail 81 : The locking screw of detail 71 , wherein the screw is configured to allow for locking in variable-angle holes for polyaxial fixation.

[0267] Detail 82: The locking screw of detail 71 , wherein the screw is configured to minimize bone loss during insertion due to its self-tapping tip.

[0268] Detail 83: The locking screw of detail 71 , wherein the screw is configured to provide superior torsional strength through the hexalobe drive.

[0269] Detail 84: The locking screw of detail 71 , wherein the screw is configured to allow for use in osteoporotic bone with minimal risk of pull-out.

[0270] Detail 85: A cortical variable angle screw (113) for use in a bone fixation system, comprising: a threaded shaft; a spherical head allowing for variable angulation; a hexalobe drive recess in the head; and a self-tapping tip.

[0271] Detail 86: The cortical variable angle screw (113) of detail 85, wherein the spherical head allows angulation in a range from about 0 degrees to about 30 degrees, optionally in a range from about 7.5 degrees to about 22.5 degrees.

[0272] Detail 87: The cortical variable angle screw (113) of detail 85, wherein the threaded shaft has a pitch in a range from about 0.2 mm to about 2 mm, optionally in a range from about 0.5 mm to about 1.5 mm.

[0273] Detail 88: The cortical variable angle screw (113) of detail 85, wherein the self-tapping tip has flutes with a relief angle of about 25 degrees.

[0274] Detail 89: The cortical variable angle screw (113) of detail 85, wherein the hexalobe drive recess has a depth in a range from about 0.2 mm to about 4 mm, optionally about 0.2 mm to about 2 mm, optionally in a range from about 0.5 mm to about 1.5 mm.

[0275] Detail 90: The cortical variable angle screw (113) of detail 85, having a major diameter in a range from about 1 mm to about 4 mm, optionally in a range from about 1.5 mm to about 3 mm.

[0276] Detail 91 : The cortical variable angle screw (113) of detail 85, wherein the screw is configured to allow for angulation to target optimal bone stock in the clavicle midshaft.PCT Patent Application Docket No.: 409948-508001 WO

[0277] Detail 92: The cortical variable angle screw (113) of detail 85, wherein the screw is configured to provide bicortical fixation through angled screw holes (104).

[0278] Detail 93: The cortical variable angle screw (113) of detail 85, wherein the screw is configured to minimize risk to supraclavicular nerves through variable angulation.

[0279] Detail 94: The cortical variable angle screw (113) of detail 85, wherein the screw is configured to provide locking stability in the plate (100) while allowing off-axis placement.

[0280] Detail 95: The cortical variable angle screw (113) of detail 85, wherein the screw is configured to allow for use in comminuted fractures by targeting butterfly fragments.

[0281] Detail 96: A method of reducing and fixing a bone fracture, comprising: positioning a multiplanar bone reduction and fixation plate (100) according to detail 1 over the bone (B); aligning the first flange (103) with a first surface of the bone (B) and the second flange (101) with a second surface of the bone (B); and securing the plate (100) to the bone (B) by inserting fasteners (107, 109, 111, 113) through the fastener holes (102, 110, 112) and angled screw holes (104).

[0282] Detail 97: The method of detail 96, further comprising accessing a midportion (M) of the bone (B) through a window (108) in the second flange (101) for direct reduction and debridement.

[0283] Detail 98: The method of detail 96, wherein inserting the fasteners includes using angled screws (113) at an angle in a range from about 0 degrees to about 90 degrees, optionally about 0 degrees to about 30 degrees, optionally in a range from about 7.5 degrees to about 22.5 degrees, to achieve optimal bone purchase.

[0284] Detail 99: The method of detail 96, further comprising adjusting screw position via sliding screw holes (106) with adjustment in a range from about 0.5 mm to about 5 mm, optionally in a range from about 1.25 mm to about 3.75 mm, to apply interfragmentary compression.

[0285] Detail 100: The method of detail 96, wherein the bone (B) is a clavicle midshaft fracture, and the method further comprises using the window (108) for placement of bone graft to enhance healing in atrophic non-unions.PCT Patent Application Docket No.: 409948-508001 WO

[0286] Detail 101 : The method of detail 96, wherein the method further comprises using a combination of locking and non-locking screws to provide both angular stability and compression.

[0287] Detail 102: The method of detail 96, wherein the method further comprises intraoperative imaging through the window (108) to confirm anatomical reduction and screw placement.

[0288] Detail 103: The method of detail 96, wherein the method further comprises using variable-angle screws (113) to avoid neurovascular structures and target dense bone stock.

[0289] Detail 104: The method of detail 96, wherein the method further comprises applying the plate (100) in a superior-inferior-anterior configuration to resist torsional forces.

[0290] Detail 105: The method of detail 96, wherein the method further comprises using the triplanar design to provide enhanced rotational stability for early postoperative mobilization.

[0291] Detail 106: The method of detail 96, wherein the method further comprises using the plate (100) in combination with cerclage wires through the window (108) for comminuted fractures.

[0292] Detail 107: The method of detail 96, wherein the method further comprises using the plate (100) in revision surgery for malunion or non-union by correcting deformity and providing rigid fixation.

[0293] Detail 108: The method of detail 96, wherein the method further comprises using the plate (100) to allow for early range of motion and return to function.

[0294] Detail 109: The method of detail 96, wherein the method further comprises using the plate (100) in a minimally invasive approach with limited exposure through the window (108).

[0295] Detail 110: The method of detail 96, wherein the method further comprises using the plate (100) to provide a bridge over the fracture site, protecting the healing process.

[0296] Detail 111: Use of the multiplanar bone reduction and fixation plate (100) according to detail 1 for the stabilization of a fractured bone (B).PCT Patent Application Docket No.: 409948-508001 WO

[0297] Detail 112: The use of detail 111, wherein the fractured bone (B) is selected from the group consisting of a clavicle, a humerus, a radius, an ulna, a femur, a tibia, a fibula, a rib, a metacarpal, a patella, and a metatarsal.

[0298] Detail 113: The use of detail 111, wherein the fractured bone (B) is a clavicle midshaft fracture, and the plate (100) provides triplanar fixation to restore length, alignment, and rotation.

[0299] Detail 114: The use of detail 111, in combination with locking screws having double-lead threads for enhanced bone purchase.

[0300] Detail 115: The use of detail 111, in combination with cortical variable angle screws (113) allowing angulation up to about 15 degrees to optimize screw trajectories.

[0301] Detail 116: The use of detail 111, in combination with bone graft material placed through the window (108) to promote biological healing.

[0302] Detail 117: The use of detail 111 , for the treatment of displaced midshaft clavicle fractures with shortening greater than 20 mm.

[0303] Detail 118: The use of detail 111 , for the treatment of non-unions or malunions requiring anatomical restoration.

[0304] Detail 119: The use of detail 111 , for the treatment of comminuted fractures requiring multiplanar stability.

[0305] Detail 120: The use of detail 111 , for the treatment of osteoporotic fractures requiring enhanced angular stability.

[0306] According to some aspects, the method of making is executed wherein the adjusting of the implant’s size, shape, and / or window is further computed using one or more artificial intelligence (Al) methods or machine learning algorithms.

[0307] In some embodiments, the methods disclosed herein are further comprising the step of: scanning a shape of the implant and using a software program to compare the shape to an image of the subject to determine if the implant is in an optimum shape and / or size for the subject or a bone of the subject. For example, the image of the subject can include an X-ray.

[0308] In any interpretation of the claims appended hereto, it is noted that no claims or claim elements are intended to invoke or be interpreted under 35 U.S.C.112(f) unless the words “means for” or “step for” are explicitly used in the particular claim.PCT Patent Application Docket No.: 409948-508001 WO

[0309] In general, any combination of disclosed features, components and methods described herein is possible. Steps of a method can be performed in any order that is physically possible.

[0310] All cited references are incorporated by reference herein. Although embodiments have been disclosed, it is not desired to be limited thereby. Rather, the scope should be determined only by the appended claims.

[0311] While various embodiments of the present disclosure have been described in detail, it is apparent that modifications and alterations of those embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications and alterations are within the scope and spirit of the present disclosure, as set forth in the following claims.

[0312] The foregoing discussion of the disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description for example, various features of the disclosure are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed disclosure requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0313] Moreover, though the present disclosure has included description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0314] The description of embodiments of the disclosure is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. While specificPCT Patent Application Docket No.: 409948-508001 WO embodiments of, and examples for, the disclosure are described herein for illustrative purposes, various equivalent modifications are possible within the scope of the disclosure, as those skilled in the relevant art will recognize. For example, while method steps or functions are presented in a given order, alternative embodiments may perform functions in a different order, or functions may be performed substantially concurrently. The teachings of the disclosure provided herein can be applied to other procedures or methods as appropriate. The various embodiments described herein can be combined to provide further embodiments. Aspects of the disclosure can be modified, if necessary, to employ the compositions, functions and concepts of the above references and application to provide yet further embodiments of the disclosure. Moreover, due to biological functional equivalency considerations, some changes can be made in protein structure without affecting the biological or chemical action in kind or amount. These and other changes can be made to the disclosure in light of the detailed description. All such modifications are intended to be included within the scope of the appended claims.

[0315] Specific elements of any of the foregoing embodiments can be combined or substituted for elements in other embodiments. Furthermore, while advantages associated with certain embodiments of the disclosure have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the disclosure. The methods, kits, formulations, and devices disclosed herein can be combined in any way into systems to address the current public health emergency.

[0316] Importantly, it is to be understood that any feature disclosed in the present description, or in the appended claims, or in the accompanying drawings, or in the examples or embodiments provided herein, whether structural, functional, material, dimensional, methodological, or otherwise, may be utilized both separately and in any combination thereof with any other such feature, regardless of whether such features are described in the context of the same embodiment or different embodiments, to realize the invention in various forms adapted to specific anatomical, biomechanical, or surgical requirements. According to some aspects, this includes, without limitation, inter-combining elements such as the multiplanar bone reduction and fixation plate 100 with its first flange 103, second flange 101 comprising first flange portion 101a and second flange portion 101b, elongatedPCT Patent Application Docket No.: 409948-508001 WO intermediate plate section 105 including first intermediate plate section 105a and second intermediate plate section 105b, window 108, angled screw holes 104, sliding screw holes 106, sets of orthogonal holes 102, 110, 112, fasteners 107, 109, 111, angled screws 113, planes of attachment 205, 210, 215, alternative versions 100' and 100" with distal end 305, locking screw 405, cortical variable angle screw 505, and any associated reference numbers, details, ranges, materials, configurations, or wording, thereby enabling diverse implementations that enhance fixation stability, promote bone healing, and accommodate varied fracture patterns across bones such as clavicle, humerus, or others. In some embodiments, such combinations extend to prophetic examples, manufacturing methods, and treatment protocols, ensuring comprehensive coverage of the inventive concept without restriction to the specific illustrations provided.

[0317] The technology described herein is further illustrated by the following examples which in no way should be construed as being further limiting. The Examples are provided to demonstrate examples of future planned work, which in some experiments is emergency work. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of this disclosure, suitable methods and materials are described below.EXAMPLES

[0318] The invention now being generally described with the spirit of the invention and inventive concept described and illustrated, it will be more readily understood by reference to the following examples which are included merely for purposes of illustration of certain aspects and embodiments of the present invention and are not intended to limit the invention. As can be discerned, the technology herein provides a great improvement in guiding surgical discectomy outcomes, and by helping quality of life, long-term, for patients, it is foreseen that the technology will grow.EXAMPLE 1. PREFERRED SURGICAL OUTCOMES WITH INTELLIGENT IMPLANTS

[0319] In this prophetic example multiplanar bone reduction and fixation plate 100 incorporates embedded sensors within first flange 103 and second flange 101 to monitor real-time strain and micromotion at the fracture site, enabling adaptive fixation that optimizes load-sharing for enhanced osteogenesis. According to some aspects, first intermediate plate section 105a and second intermediate plate section 105b integrate bioresorbable coatings on angled screw holes 104 and sliding screwPCT Patent Application Docket No.: 409948-508001 WO holes 106, facilitating controlled drug release of osteoinductive agents through window 108 to accelerate callus formation in comminuted clavicle fractures. In some embodiments, first set of orthogonal holes 102 and second set of orthogonal holes 110 receive locking screws 405 with variable angle capabilities, providing polyaxial stability that resists torsional forces from shoulder girdle activities while minimizing peri-implant bone resorption. In this example, cortical variable angle screw 505 engages third set of orthogonal screw holes 112, with its spherical head allowing up to 15 degrees of angulation to target optimal cortical purchase, thereby reducing nonunion risks in osteoporotic patients. In a non-limiting example, the intelligent implant system transmits biomechanical data via wireless telemetry from elongated intermediate plate section 105, guiding postoperative rehabilitation protocols for personalized recovery, resulting in superior functional outcomes and decreased revision rates. According to some aspects, this configuration supports minimally invasive approaches, where angled screws 113 and first set of fasteners 107 promote primary healing through precise interfragmentary compression, fostering rapid return to mobility in active individuals.EXAMPLE 2. METHODS OF TREATING PATIENTS

[0320] After manufacturing is developed (e.g., see FIGS. 6A-6D and FIGS.7A-7D), in this prophetic example, multiplanar bone reduction and fixation plate 100 is implanted in patients with midshaft clavicle fractures via a minimally invasive anterior approach, where first flange 103 aligns with the superior bone surface and second flange 101 conforms to the inferior aspect, connected by elongated intermediate plate section 105 to provide triplanar stability that restores anatomical alignment and facilitates early shoulder mobilization. According to some aspects, locking screw 405 engages first set of orthogonal holes 102 and second set of orthogonal holes 110 for fixed-angle fixation, while cortical variable angle screw 505 inserts through angled screw holes 104 at up to 15 degrees divergence, optimizing cortical purchase in osteoporotic bone and reducing nonunion rates by promoting interfragmentary compression. In some embodiments, window 108 allows intraoperative graft placement at mid-portion of the bone M, augmented with biologies released from screw coatings, accelerating osteogenesis and improving functional scores in elderly patients. In this example, sliding screw holes 106 accommodate dynamic adjustment with first set of fasteners 107, enabling controlled micromotion that stimulates secondary healing in active individuals, therebyPCT Patent Application Docket No.: 409948-508001 WO shortening rehabilitation periods and enhancing quality of life through preserved range of motion. In a non-limiting example, the system integrates telemetry from embedded sensors in first intermediate plate section 105a and second intermediate plate section 105b, monitoring healing progression to guide personalized therapy, resulting in decreased complication rates and superior long-term outcomes for diverse patient populations.REFERENCES:1IIIPAC. International Union of Pure and Applied Chemistry GoldBook.https: / / goldbook.iupac.org / .2Merriam-Webster's Online Dictionary, https: / / www.merriam-webster.com / .3Porter R. S., & Kaplan, J. L. (Eds.). The Merck manual of diagnosis and therapy (19th ed.).Merck Sharp & Dohme Corp.. 2011, (978-0-911910-19-3).4Robert S. Porter et al., (eds.). The Encyclopedia of Molecular Cell Biology and Molecular Medicine. Blackwell Science Ltd.; 1999-2012, (9783527600908).5Robert A. Meyers (ed.). Molecular Biology and Biotechnology: A Comprehensive Desk Reference. VCH Publishers, Inc.; 1995, (1-56081-569-8).6Luttmann Werner. Immunology. Elsevier; 2006,7Kenneth Murphy Allan Mowat, Casey Weaver (eds.). Janeway's Immunobiology. Taylor & Francis Limited; 2014, (9780815345305).8Krebs Jocelyn E., et al. Lewin's genes XI. 11th ed. Burlington, Mass.: Jones & Bartlett Learning; 2014, (1449659055).9Green Michael R. Molecular cloning : a laboratory manual / Michael R. Green, Joseph Sambrook. Cold Spring Harbor, N.Y: Cold Spring Harbor Laboratory Press; 2012, (1936113414).10Davis etal. Basic Methods in Molecular Biology. Elsevier Science Publishing, Inc.; 2012, (044460149X).11Jon Lorsch (ed.). Laboratory Methods in Enzymology: DNA. Elsevier; 2013, (0124199542).12Frederick M. Ausubel (ed.). Current Protocols in Molecular Biology (CPMB). John Wiley and Sons 2014, (9780471503385).13John E. Coligan (ed.). Current Protocols in Protein Science (CPPS). John Wiley and Sons, Inc.; 2005,14John E. Coligan ADA M Kruisbeek, David H Margulies, Ethan M Shevach, Warren Strobe, (eds.) Current Protocols in Immunology (CPI). John Wiley and Sons, Inc.; 2003, (9780471142737).PCT Patent Application Docket No.: 409948-508001 WO

[0321] All patents and other publications; including literature references, issued patents, published patent applications, and co-pending patent applications; cited throughout this application are expressly incorporated herein by reference for the purpose of describing and disclosing, for example, the methodologies described in such publications that might be used in connection with the technology described herein. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicants and does not constitute any admission as to the correctness of the dates or contents of these documents.

[0322] The foregoing written specification and figures are considered to be sufficient to enable one skilled in the art to practice the present aspects and embodiments. The present aspects and embodiments are not to be limited in scope by examples provided, since the examples are intended as a single illustration of one aspect and other functionally equivalent embodiments are within the scope of the disclosure. Various modifications in addition to those shown and described herein will become apparent to those skilled in the art from the foregoing description and fall within the scope of the appended claims. The advantages and objects described herein are not necessarily encompassed by each embodiment. Those skilled in the art will recognize or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. Such equivalents are intended to be encompassed by the following exemplary claims.

Claims

1. PCT Patent Application Docket No.: 409948-508001 WO CLAIMSWe claim:

1. Amultiplanar bone reduction and fixation plate (100) comprising: an elongated planar first flange (103) contoured to overlay and substantially conform to a first surface of a bone (B); an elongated second flange (101) configured to overlay and substantially conform to a second surface of the bone (B); and an elongated intermediate plate section (105) extending between the first flange (103) and the second flange (101 ), wherein the first flange (103), the second flange (101 ), and the intermediate plate section (105) are each configured with respective sets of fastener holes (102, 110, 112) for receiving fasteners (107, 109, 111 ) to affix the plate (100) to the bone (B), and wherein the plate (100) defines three planes of attachment (205, 210, 215).

2. The multiplanar bone reduction and fixation plate (100) of claim 1 , wherein the second flange (101) comprises first and second flange portions (101a, 101b) with a window (108) therebetween for allowing access to a mid-portion (M) of the bone (B).

3. The multiplanar bone reduction and fixation plate (100) of claim 2, wherein the intermediate plate section (105) comprises first and second intermediate plate sections (105a, 105b), the first intermediate plate section (105a) extending between the first flange (103) and the first flange portion (101a), and the second intermediate plate section (105b) extending between the first flange (103) and the second flange portion (101b).

4. The multiplanar bone reduction and fixation plate (100) of claim 3, wherein the first flange (103) includes first and second angled screw holes (104) defined through a surface thereof in a region over the window (108).

5. The multiplanar bone reduction and fixation plate (100) of claim 4, wherein the angled screw holes (104) are configured to receive angled screws (113) at an angulation in a range from about 0 degrees to about 90 degrees, optionally about 0PCT Patent Application Docket No.: 409948-508001 WO degrees to about 30 degrees, optionally in a range from about 7.5 degrees to about 22.5 degrees.

6. The multiplanar bone reduction and fixation plate (100) of claim 3, wherein the first flange (103) includes first and second sliding screw holes (106) defined through a surface thereof.

7. The multiplanar bone reduction and fixation plate (100) of claim 6, wherein the sliding screw holes (106) have an elongated shape allowing for sliding adjustment back and forth in a range from about 0.5 mm to about 5 mm, optionally in a range from about 1.25 mm to about 3.75 mm.

8. The multiplanar bone reduction and fixation plate (100) of claim 1 , wherein the first flange (103) comprises a counter-arc profile.

9. The multiplanar bone reduction and fixation plate (100) of claim 8, wherein the counter-arc profile has a radius in a range from about 10 mm to about 100 mm, optionally in a range from about 25 mm to about 75 mm.

10. The multiplanar bone reduction and fixation plate (100) of claim 1, wherein the plate (100) is contoured for a bone (B) selected from the group consisting of a clavicle, a humerus, a radius, an ulna, a femur, a tibia, a fibula, a rib, a metacarpal, a patella, and a metatarsal.

11. The multiplanar bone reduction and fixation plate (100) of claim 10, wherein the plate (100) is specifically contoured for a clavicle with an overall length in a range from about 50 mm to about 200 mm, optionally in a range from about 75 mm to about 150 mm.

12. The multiplanar bone reduction and fixation plate (100) of claim 1, wherein the intermediate plate section (105) includes at least one chamfered section.PCT Patent Application Docket No.: 409948-508001 WO 13. The multiplanar bone reduction and fixation plate (100) of claim 12, wherein the chamfered section has a chamfer angle in a range from about 20 degrees to about 80 degrees, optionally in a range from about 30 degrees to about 60 degrees.

14. The multiplanar bone reduction and fixation plate (100) of claim 1, wherein the plate (100) is fabricated from stainless steel Type 316L.

15. The multiplanar bone reduction and fixation plate (100) of claim 1, wherein the plate (100) has a thickness in a range from about 0.5 mm to about 5 mm, optionally in a range from about 1.25 mm to about 3.75 mm.

16. The multiplanar bone reduction and fixation plate (100) of claim 2, wherein the window (108) has a width in a range from about 5 mm to about 50 mm, optionally in a range from about 12.5 mm to about 37.5 mm.

17. The multiplanar bone reduction and fixation plate (100) of claim 1, further comprising a distal end (305) in an alternative version (100").

18. The multiplanar bone reduction and fixation plate (100) of claim 17, wherein the distal end (305) is configured for extension along the bone (B) in a version (100') without the window (108).

19. A bone fixation system comprising: the multiplanar bone reduction and fixation plate (100) of claim 1 ; and a plurality of fasteners (107, 109, 111, 113) configured for insertion into the orthogonal fastener holes (102, 110, 112) and angled screw holes (104).

20. The bone fixation system of claim 19, wherein at least one fastener is a locking screw having a diameter in a range from about 1 mm to about 5 mm, optionally in a range from about 1.75 mm to about 3.75 mm.

21. The bone fixation system of claim 20, wherein the locking screw has a doublelead thread with a lead in a range from about 0.2 mm to about 1.5 mm, optionally in a range from about 0.35 mm to about 1 mm.PCT Patent Application Docket No.: 409948-508001 WO22. The bone fixation system of claim 19, wherein at least one fastener is a cortical variable angle screw (113) allowing for angulation up to about 15 degrees.

23. The bone fixation system of claim 22, wherein the cortical variable angle screw has a spherical head with a radius in a range from about 0.5 mm to about 3 mm, optionally in a range from about 0.875 mm to about 2 mm.

24. The bone fixation system of claim 19, wherein the fasteners include self-tapping tips with flutes spaced at about 120 degrees.

25. The bone fixation system of claim 19, wherein the fasteners have hexalobe drive recesses with a depth in a range from about 0.5 mm to about 3 mm, optionally in a range from about 0.875 mm to about 2 mm.

26. The bone fixation system of claim 19, wherein the fasteners have lengths in a range from about 5 mm to about 50 mm, optionally in a range from about 12.5 mm to about 37.5 mm.

27. The bone fixation system of claim 19, wherein the fasteners are fabricated from stainless steel Type 316L.

28. A locking screw for use in a bone fixation system, comprising: a threaded shaft with a double-lead thread; a head with a hexalobe drive recess; and a self-tapping tip with flutes.

29. The locking screw of claim 28, wherein the threaded shaft has a major diameter in a range from about 1 mm to about 5 mm, optionally in a range from about 1.75 mm to about 3.75 mm.

30. The locking screw of claim 28, wherein the double-lead thread has a pitch in a range from about 0.2 mm to about 1.5 mm, optionally in a range from about 0.35 mm to about 1 mm.PCT Patent Application Docket No.: 409948-508001 WO 31. The locking screw of claim 28, wherein the self-tapping tip has a relief angle of about 20 degrees.

32. The locking screw of claim 28, wherein the hexalobe drive recess has an inner diameter in a range from about 0.5 mm to about 3 mm, optionally in a range from about 0.875 mm to about 2 mm.

33. The locking screw of claim 28, having an overall length in a range from about 5 mm to about 50 mm, optionally in a range from about 12.5 mm to about 37.5 mm.

34. The locking screw of claim 28, further comprising an undercut beneath the head with an axial length.

35. A cortical variable angle screw (113) for use in a bone fixation system, comprising: a threaded shaft; a spherical head allowing for variable angulation; a hexalobe drive recess in the head; and a self-tapping tip.

36. The cortical variable angle screw (113) of claim 35, wherein the spherical head allows angulation in a range from about 0 degrees to about 90 degrees, optionally 0 degrees to about 30 degrees, optionally in a range from about 7.5 degrees to about 22.5 degrees.

37. The cortical variable angle screw (113) of claim 35, wherein the threaded shaft has a pitch in a range from about 0.2 mm to about 2 mm, optionally in a range from about 0.5 mm to about 1.5 mm.

38. The cortical variable angle screw (113) of claim 35, wherein the self-tapping tip has flutes with a relief angle of about 25 degrees.

39. The cortical variable angle screw (113) of claim 35, wherein the hexalobe drive recess has a depth in a range from about 0.2 mm to about 4 mm, optionally about 0.2 mm to about 2 mm, optionally in a range from about 0.5 mm to about 1.5 mm.PCT Patent Application Docket No.: 409948-508001 WO 40. The cortical variable angle screw (113) of claim 35, having a major diameter in a range from about 1 mm to about 4 mm, optionally in a range from about 1.5 mm to about 3 mm.

41. A method of reducing and fixing a bone fracture, comprising: positioning a multiplanar bone reduction and fixation plate (100) according to claim 1 over the bone (B); aligning the first flange (103) with a first surface of the bone (B) and the second flange (101) with a second surface of the bone (B); and securing the plate (100) to the bone (B) by inserting fasteners (107, 109, 111, 113) through the fastener holes (102, 110, 112) and angled screw holes (104).

42. The method of claim 41 , further comprising accessing a mid-portion (M) of the bone (B) through a window (108) in the second flange (101).

43. The method of claim 41 , wherein inserting the fasteners includes using angled screws (113) at an angle in a range from about 0 degrees to about 90 degrees, optionally about 0 degrees to about 30 degrees, optionally in a range from about 7.5 degrees to about 22.5 degrees.

44. The method of claim 41 , further comprising adjusting screw position via sliding screw holes (106) with adjustment in a range from about 0.5 mm to about 5 mm, optionally in a range from about 1.25 mm to about 3.75 mm.

45. The method of claim 41 , wherein the bone (B) is a clavicle.

46. The method of claim 41 , using fasteners with self-tapping tips.

47. Use of the multiplanar bone reduction and fixation plate (100) according to claim 1 for the stabilization of a fractured bone (B).

48. The use of claim 47, wherein the fractured bone (B) is selected from the group consisting of a clavicle, a humerus, a radius, an ulna, a femur, a tibia, a fibula, a rib, a metacarpal, a patella, and a metatarsal.PCT Patent Application Docket No.: 409948-508001 WO 49. The use of claim 47, in combination with locking screws having double-lead threads.

50. The use of claim 47, in combination with cortical variable angle screws (113) allowing angulation up to about 15 degrees.

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