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Delete 		PER-10 The provision module 1830 is configured to provide a preliminary cutting guide model 1838. The provision module 1830 may use a variety of methods to provide the preliminary cutting guide model. In one embodiment, the provision module 1830 may generate preliminary cutting guide model. In the same or an alternative embodiment, the provision module 1830 may select a template cutting guide model for an osteotomy procedure configured to correct the deformity identified by the deformity module 1820. In one embodiment, the provision module 1830 may select a template cutting guide model from a set of template cutting guide models (e.g., a library, set, or repository of template cutting guide models). 189 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 The registration module 1840 registers the preliminary cutting guide model with one or more bones or other anatomical structures of the bone model 1804. As explained above, registration is a process of combining medical imaging data, patient imaging data, and/or one or more models such that the preliminary cutting guide model can be used with the bone model 1804. 190 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 The design module 1850 designs a patient specific cutting guide (or patient specific cutting guide model) based on the preliminary cutting guide model. The design operation of the design module 1850 may be completely automated, partially automated, or completely manual. A user may control how automated or manual the designing of the patient specific cutting guide (or patient specific cutting guide model) is. 191 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 The manufacturing module 1860 may manufacture a patient specific cutting guide 1806 using the preliminary cutting guide model. The manufacturing module 1860 may use a patient specific cutting guide model generated from the preliminary cutting guide model. The manufacturing module 1860 may provide the patient specific cutting guide model to one or more manufacturing tools and/or fabrication tool. The patient specific cutting guide model may be sent to the tools in any format such as an STL file or any other CAD modeling or CAM file or method for data exchange. In one embodiment, a user can adjust default parameters for the patient specific cutting guide such as types and/or thicknesses of materials, dimensions, and the like before the manufacturing module 1860 provides the patient specific cutting guide model to a manufacturing tool. 192 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 Figures 19A-19H are top perspective, top perspective, bottom, front elevation, rear elevation, right, left, and alternative top perspective, respectively, of a patient-specific cutting guide, or cutting guide 1900, according to one alternative embodiment. 193 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 The cutting guide 1900 may be designed to facilitate resection of a first cuneiform near a distal end and a first metatarsal near a proximal end with planar cuts at the proper angles to provide dual-plane correction of the orientation of the first metatarsal relative to the first cuneiform, thereby providing correction in a lateral direction, in a plantar direction, and/or a dorsal direction. 194 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 As shown, the cutting guide 1900 may have a body 1910 with a monolithic construction and the general shape of a rectangular prism. As used herein, a "body" refers to a main or central part of a structure. The body may serve as a structural component to connect, interconnect, surround, enclose, and/or protect one or more other structural components. A body may be made from a variety of materials including, but not limited to, metal, plastic, ceramic, wood, fiberglass, acrylic, carbon, biocompatible materials, biodegradable materials or the like. A body may be formed of any biocompatible materials, including but not limited to biocompatible metals such as Titanium, Titanium alloys, stainless steel alloys, cobalt-chromium steel alloys, nickel-titanium alloys, shape memory alloys such as Nitinol, biocompatible ceramics, and biocompatible polymers such as Polyether ether ketone (PEEK) or a polylactide polymer (e.g. PLLA) and/or others. In one embodiment, a body may include a housing or frame or framework for a larger system, component, structure, or device. A body may include a modifier that identifies a particular function, location, orientation, operation, and/or a particular structure relating to the body. Examples of such modifiers applied to a body, include, but are not limited to, "inferior body," "superior body," "lateral body," "medial body," and the like. 195 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 The body 1910 includes a proximal side 1912, a distal side 1914, a medial side 1916, a lateral side 1918, a superior side 1920, and an inferior side 1922. In the illustrated embodiment, the body 1910 may also include a proximal arm 1930 that extends from the body 1910 and a distal arm 1940 that extends from the body 1910. The proximal side 1912 is the side closest to the core of the patient when the cutting guide 1900 is in use. The distal side 1914 is the side furthest from the core of the patient when the cutting guide 1900 is in use. The medial side 1916 is the side facing medially when the cutting guide 1900 is in use. The lateral side 1918 is the side facing laterally when the cutting guide 1900 is in use. The superior side 1920 is the side facing up away from the bone(s) when the cutting guide 1900 is in use. The inferior side 1922 is the side facing down, facing, and/or contacting the bone(s) (e.g., contacting a surface of one or more bones) when the cutting guide 1900 is in use. 196 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 The inferior side 1922 may be custom contoured to match the shapes of one or more of the surfaces of the first cuneiform and/or the first metatarsal. In one embodiment, the inferior side 1922 may include a bone engagement surface 1924. The bone engagement surface 1924 can be shaped to match a first surface of a first bone and a second surface of a second bone of a joint. 197 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 As used herein, "bone engagement surface" refers to a surface of an object, instrument, or apparatus, such as an implant that is oriented toward or faces one or more bones of a patient. In one aspect, the bone engagement surface may abut, touch, or contact a surface of a bone. In another aspect, the bone engagement surface or parts of the bone engagement surface may be close to, but not abut, touch, or contact a surface of the bone. In certain aspects, the bone engagement surface can be configured to engage with a surface of one or more bones. Such a bone engagement surface may include projections and recesses that correspond to and match projections and recesses of the one or more bone surfaces. 198 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 Figure 18 illustrates an exemplary system 1800 configured to generate one or more patient specific instruments configured to correct a bone condition, according to one embodiment. "Bone condition" refers to any of a variety of conditions of bones of a patient. Bone conditions may be caused by or result from deformities, misalignment, malrotation, fractures, joint failure, and/or the like. A bone condition includes, but is not limited to, any angular deformities of one or more bone segments in either the lower or upper extremities (for example, tibial deformities, calcaneal deformities, femoral deformities, and radial deformities). "Malrotation" refers to a condition in which a part, typically a part of a patient's body has rotated from a normal position to an unnormal or uncommon position. The system 1800 may include an apparatus 1802 configured to accept, review, receive or reference a bone model 1804 and provide a patient specific cutting guide 1806. In one embodiment, the apparatus 1802 is a computing device. In another embodiment, the apparatus 1802 may be a combination of computing devices and/or software components or a single software component such as a software application. 184 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 In one example, the bone engagement surface 1924 can be shaped such that the bone engagement surface 1924 matches a surface of a cuneiform bone and a surface of a metatarsal bone of a tarsometatarsal (“TMT”) joint. The bone engagement surface 1924 can be so shaped because it is fabricated from a bone model of the patient’s bones. The body 1910 is configured, designed, and/or fabricated to seat transverse to a joint (e.g., a TMT joint) with the bone engagement surface 1924 engaging a first surface of a first bone and a second surface of a second bone. 200 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 In one embodiment, the body 1910 is configured to reside on the dorsal surfaces of the first cuneiform and the first metatarsal to provide proper alignment of the body 1910 with the metatarsocuneiform joint (e.g., the joint between the first metatarsal and the medial cuneiform bone, aka a TMT joint). In another embodiment, the body 1910 is configured to reside or sit between the medial surfaces and the dorsal surfaces, or on the medial surfaces of the first cuneiform and the first metatarsal to provide proper alignment of the body 1910 with the metatarsocuneiform joint (e.g., the joint between the first metatarsal and the medial cuneiform bone) for an osteotomy. 201 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 In certain embodiments, the bone engagement surface 1924 may include a cuneiform apposition portion 1926 and a metatarsal apposition portion 1928. As shown, the cuneiform apposition portion 1926 may be contoured to match the contour of the surface of the first cuneiform on which it is to rest, and the metatarsal apposition portion 1928 may similarly be contoured to match the contour of the surface of the first metatarsal on which it is to rest. (See FIG. 19C) Thus, the body 1910 may have only one stable position and orientation relative to the first cuneiform and the first metatarsal during a surgical osteotomy for correcting the condition. 202 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 Advantageously, the fidelity of the patient imaging data enables the bone model, preliminary cutting guide model, and patient specific instrument (e.g., patient specific cutting guide, patient specific pin guide, patient specific alignment guide, etc.) to uniquely match a particular patient. Consequently, the bone engagement surface 1924 can engage the surfaces of the bones of a joint in a single configuration. Such a close matching fit facilitates the surgical osteotomy. 203 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 FIG. 19D illustrates the cutting guide 1900 from a view facing the medial side 1916. FIG. 19E illustrates the cutting guide 1900 from a view facing the lateral side 1918. In certain embodiments, the cutting guide 1900 may include one or more features that facilitate use of the cutting guide 1900 while avoiding certain soft tissue in the vicinity of a joint. For example, the medial side 1916 may include a medial superior surface 1932 and a medial inferior surface 1934 that meet at a medial edge 1936. Advantageously, the medial inferior surface 1934 may extend from inferior side 1922 to the medial edge 1936 at an angle such that the medial inferior surface 1934 does not impinge soft tissue near the joint (e.g., near a medial end of the joint). In certain embodiments, the angle may range between about 80 and about 170 degrees. In another example, the lateral side 1918 may include a lateral superior surface 1942 and a lateral inferior surface 1944 that meet at a lateral edge 1946. Of course, the medial superior surface 1932 may extend from the superior side 1920 to the medial edge 1936 at an angle. The angle of the medial superior surface 1932 may enable use of the cutting guide 1900 in tighter openings and thus minimize the size of incisions used for a procedure. 204 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 Advantageously, the lateral inferior surface 1944 may extend from inferior side 1922 to the lateral edge 1946 at an angle such that the lateral inferior surface 1944 does not impinge soft tissue near the joint (e.g., near a medial end of the joint). In certain embodiments, the angle may range between about 80 and about 170 degrees. Of course, the lateral superior surface 1942 may extend from the superior side 1920 to the lateral edge 1946 at an angle. The angle of the lateral superior surface 1942 may enable use of the cutting guide 1900 in tighter openings and thus minimize the size of incisions used for a procedure. 205 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 The body 1910 may further include guide features that guide a cutter to resect the first cuneiform and the first metatarsal in the manner needed to make the desired correction. For example, the guide features may be used to guide a planar cutting blade, an arcuate cutting blade, a drill or mill, a burr, and/or the like. 206 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 In the embodiment of Figures 19A through 19H, the guide features may guide a reciprocating planar blade, such as that of a surgical bone saw, that forms planar cuts in the first cuneiform and the first metatarsal. Various manual or powered tools may be used to form the planar cuts. In one embodiment, a sagittal bone saw can be used. In one example, the guide features may take the form of a first slot 1960 and a second slot 1970. The first slot 1960 may include a lateral end 1962 and a medial end 1964. The second slot 1970 may include a lateral end 1972 and a medial end 1974. 207 Added by DJM 2 2022 2/25/22, 12:00 AM
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Delete 		PER-10 In one embodiment, the first slot 1960 and the second slot 1970 extend from the superior side 1920 to the inferior side 1922. In certain embodiments, the first slot 1960 may extend from near the lateral side 1918 to near the medial side 1916. In other embodiments, one of, or both of, the first slot 1960 and the second slot 1970 may extend from one of the medial side 1916 or the lateral side 1918 of the body 1910. In certain embodiments, the first slot 1960 and second slot 1970 intersect. In other embodiments, the first slot 1960 and second slot 1970 do not intersect. 208 Added by DJM 2 2022 2/25/22, 12:00 AM

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