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Delete 		NXT-5PROV NXT-5, 6, 7, 8 Figure 15 is a perspective view of a fastener, according to one embodiment. 33 Added by DJM 8 2021 8/16/21, 12:00 AM
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Delete 		INS-4PROV I have included the patent that Amendia / Vivex filed that looked at a process called Mimetic etching.  Here they demonstrated bone growth into the treated cage without the use of allo or autograft (empty cage) in a sheep model. The process was laser etching of the cage to generate a micro architecture which was felt to mimic cancellous bone.  …This initiated out of a project with NASA laser project.  This process was very expensive and time consuming.  The interesting fact is they treated a block of quartz with this process and used the block to run electric devices in space (i.e. a battery)….[It seems that Mimetic etching] is possible and potentially an economical way to develop a surface technology.  The other thing to remember is that it does not appear that carbon products act under electromagnetic fields like metallic materials do (heat, field distortion, etc.). 65 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV Referring now to FIG. 20A, in one embodiment, the deformity module 1820 starts by identifying a center longitudinal axis 1828a, 1828b (Fig. 20A shows two of the plurality of axes for clarity) for each bone in the bone model 1804. For example, the deformity module 1820 may identify the center longitudinal axis 1828a for a first metatarsal and the center longitudinal axis 1828b for the second metatarsal. 170 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV The determination module 1810 determines anatomic data 1812 from a bone model 1804. In certain embodiments, the system 1800 may not include a determination module 1810 if the anatomic data is available directly from the bone model 1804. In certain embodiments, the anatomic data for a bone model 1804 may include data that identifies each anatomic structure within the bone model 1804 and attributes about the anatomic structure. For example, the anatomic data may include measurements of the length, width, height, and density of each bone in the bone model. Furthermore, the anatomic data may include position information that identifies where each structure, such as a bone is in the bone model 1804 relative to other structures, including bones. The anatomic data may be in any suitable format and may be stored separately or together with data that defines the bone model 1804. 157 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV In one embodiment, the determination module 1810 may use advanced computer analysis such as image segmentation to determine the anatomic data. Alternatively, or in addition the determination module 1810 may use software and/or systems that implement one or more artificial intelligence methods (e.g., machine learning and/or neural networks) for deriving, determining, or extrapolating, anatomic data from the bone model. In one embodiment, the determination module 1810 may perform an anatomic mapping of the bone model 1804 to determine each unique aspect of the intended osteotomy procedure and/or bone resection and/or bone translation. The anatomic mapping may be used to determine coordinates to be used for an osteotomy procedure, position and manner of resections to be performed either manually or automatically or using robotic surgical assistance, a width for bone cuts, an angle for bone cuts, a predetermined depth for bone cuts, dimensions and configurations for resection instruments such as saw blades, milling bit size and/or speed, saw blade depth markers, and/or instructions for automatic or robotic resection operations. 158 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV The deformity module 1820 determines or identifies one or more deformities or other anomalies based on the anatomic data 1812. The deformity may include a deformity between two bones of a patient’s foot as represented in the bone model 1804. In one embodiment, the deformity module 1820 may compare the anatomic data 1812 to a general model that is representative of most patient’s anatomies and that does not have a deformity or anomaly. In one embodiment, if the anatomic data 1812 does not match the general model a deformity is determined. Various deformities may be detected including those that have well-known names for the condition and those that are unnamed. 159 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV The selection module 1830 is configured to select a template cutting guide model 1832 for an osteotomy procedure configured to correct the deformity identified by the deformity module 1820. In one embodiment, the selection module 1830 may select a template cutting guide model 1832 from a set of template cutting guide models 1832 (e.g., a library, set, or repository of template cutting guide models 1832). In one embodiment, the template cutting guide model 1832 may include digital models. In another embodiment, the template cutting guide model 1832 may include physical models. In such an embodiment, the repository 2102 may be a warehouse or other inventory repository. Where the template cutting guide model 1832 are physical models, the systems, modules, and methods of this disclosure can be used and the physical model may be milled or machined (e.g., a CNC machine) to form a patient specific cutting guide that conforms to the bone surfaces of the patient. 160 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV Selection of a suitable template cutting guide model 1832 may be completely automated and/or may be partially automated and/or may depend on confirmation from a user before a proposed template cutting guide model 1832 becomes the selected template cutting guide model 1834. In another embodiment, the selection module 1830 may facilitate a manual selection by a user of the template cutting guide model 1832. The selection module 1830 may use the anatomic data 1812 or the bone model 1804 or a combination of these to select a suitable template cutting guide model (also referred to as a selected template cutting guide model 1834). 161 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV The registration module 1840 registers the selected template cutting guide model 1834 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 selected template cutting guide model 1834 can be used with the bone model 1804. 162 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV The design module 1850 designs a patient specific cutting guide (or patient specific cutting guide model) based on the selected template 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. 163 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV The manufacturing module 1860 may manufacture a patient specific cutting guide 1806 using the selected template cutting guide model 1834. The manufacturing module 1860 may use a patient specific cutting guide model generated from the selected template cutting guide model 1834. 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. 164 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV Figure 19 illustrates an exemplary deformity module 1820 configured to determine a deformity, according to one embodiment. The deformity module 1820 may detect one or more deformities and/or anomalies of a patient’s anatomy by analyzing anatomic data 1812 and other inputs, such as a certain type or class of deformities to search for. 165 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV The deformity module 1820 may be completely automated, partially automated, or completely manual. A user may control how automated or manual the detection of the deformity is. The user may provide instructions to the deformity module 1820 to facilitate automatic or partially automated detection or determination of one or more deformities. 166 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV The deformity module 1820 may include a deformity detection module 1822. The deformity detection module 1822 may be configured for automated determination of a deformity. For example, in one embodiment, the deformity detection module 1822 includes an artificial intelligence or machine learning module 1824. The artificial intelligence or machine learning module 1824 is configured to implement one or more of a variety of artificial intelligence modules that may be trained for detecting an anomaly or deformity based on anatomic data 1812. In another embodiment, the deformity module 1820 may receive patient imaging data, a bone model, a CAD model or the like and use these inputs to determine deformities in the bones of a patient. 167 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV In one embodiment, the artificial intelligence or machine learning module 1824 may be trained using a large data set of anatomic data 1812 for healthy non-deformed bones and a large data set of anatomic data 1812 for deformed bones in which the deformity has been previously identified and labeled in the dataset. The artificial intelligence or machine learning module 1824 may implement, or use, a neural network configured according to the training such that as the artificial intelligence or machine learning module 1824 accepts the anatomic data 1812 for a particular patient, the artificial intelligence or machine learning module 1824 is able to determine what deformity 1826 exists in the patient’s bones, when such a deformity 1826 exists. 168 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV Figures 20A and 20B illustrates one example of a method for determining a deformity and a correction for the deformity, according to one embodiment. The deformity module 1820 may use a particular method for determining whether or not two or more bones have a deformity 1826. The deformity module 1820 may use one or more advanced computing techniques for determining the deformity 1826. 169 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV The apparatus 1802 may include a determination module 1810, a deformity module 1820, a selection module 1830, a registration module 1840, a design module 1850, and a manufacturing module 1860. Each of which may be implemented in one or more of software, hardware, or a combination of hardware and software. 156 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV Next, the deformity module 1820 may identify a reference axis 1829 perpendicular with one of the center longitudinal axes 1828a,b, such as center longitudinal axis 1828b. The reference axis 1829 may be at or near a joint between bones of the bone model 1804. The deformity module 1820 may determine that a deformity 1826 exists if the center longitudinal axes 1828a,b are not parallel or are not parallel when measured with a predefined margin for error. FIG. 20A illustrates a bone model 1804 with a deformity 1826. The deformity 1826 is that the first metatarsal is not parallel or not sufficiently parallel to the second metatarsal at the joint between the first metatarsal and the medial cuneiform bones. Once the deformity 1826 is determined, the deformity module 1820 or apparatus 1802 may determine what steps, procedures, or instrumentation can be used to correct the deformity 1826. The deformity module 1820 may use a name, label, tag, or other identifier for a particular deformity 1826. 171 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV FIG. 20B illustrates the bone model 1804 of FIG. 20A after a corrective procedure and/or application of corrective implants may be performed. The center longitudinal axes 1828a,b are parallel, or sufficiently parallel, such that the deformity 1826 is not a problem for a patient. 172 Added by DJM 7 2021 7/2/21, 12:00 AM
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Delete 		PER-8 PROV Figure 21 illustrates an exemplary selection module 1830 configured to select a template cutting guide model, according to one embodiment. The selection module 1830 may accept anatomic data 1812 and a designation, identifier, label, or name of a deformity 1826. In the illustrated embodiment, the selection module 1830 may select a template cutting guide model 1832 automatically from a set of template cutting guide models 1832 stored in a repository 2102. The selection module 1830 may incorporate a variety of parameters in order to determine or select a template cutting guide model 1832. For example, in addition to the anatomic data 1812, the selection module 1830 may include patient imaging data, deformity parameters for a variety of angular deformities (in all 3 planes) of the midfoot or hind foot and ankle where an osteotomy could be used, patient preferences, and/or surgeon input parameters. 173 Added by DJM 7 2021 7/2/21, 12:00 AM

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