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IPP-0050-US35 nextremity In certain embodiments, the relative orientations are orientations of the guide 2002 and/or its members in relation to the bone fastener 804. In one embodiment, the engagement member 2018 couples the guide 2002 to the bone fastener 804 directly. In another embodiment, the engagement member 2018 couples the guide 2002 to the bone fastener 804 indirectly by way of an inserter 806. In one embodiment, the engagement member 2018 may be coupled to the body 2014 near the distal end 2022. In the illustrated embodiment, the engagement member 2018 is coupled to the body 2014 at the distal end 2022. 171 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity In one embodiment, the engagement member 2018 couples the guide 2002 to the bone fastener 804. For example, in one embodiment the engagement member 2018 engages the bone fastener 804 such that the guide member 2016 is rotatable relative to the bone fastener 804 about an engagement axis 412 to a plurality of relative orientations. In another example, the engagement member 2018 engages the bone fastener 804 such that the guide 2002 is rotatable relative to the bone fastener 804 about an engagement axis 412 to a plurality of relative orientations. 170 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity In one embodiment, the guide member 2016 includes a passage through the guide member 2016 defining the cross fixation insertion axis 420 and one or more sleeves 2008a,b received in the passage in axial sliding relationship. In one embodiment, a passage of the guide member 2016 is sized to accept one or more sleeves 2008. Each sleeve 2008 may include an axial through passage having a cross-sectional diameter sized to permit the sleeve 2008 to slide axially within the passage. In the illustrated embodiment, the sleeves 2008a,b may each have different cross-sectional diameters that permit certain ones of the one or more sleeves 2008a,b to fit within each other in a nested configuration such that a longitudinal axis of the sleeves 2008a,b aligns with the fixation insertion axis 420. 169 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity The guide member 2016 may facilitate or enable preparation of a site for deployment of a fixation member 812. Alternatively, or in addition, the guide member 2016 may serve to guide deployment of a fixation member 812 to secure a bone fastener 804. In one embodiment, the guide member 2016 may be coupled to the body 2014 near the proximal end 2020. In the illustrated embodiment, the guide member 2016 is coupled to the body 2014 at the proximal end 2020. 168 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 57 is a side view of a system 2000 that includes a guide 2002 according to one embodiment of the present disclosure. In one embodiment, the guide 2002 includes a body 2014, a guide member 2016, and an engagement member 2018. The body 2014 has a proximal end 2020 and a distal end 2022. In one embodiment, the body 2014 has an arc or acuate shape and may resemble an “arm” that extends between the proximal end 2020 and the distal end 2022. 167 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity In various embodiments of the present disclosure the inferior surface 1056 and/or superior surface 1058 may be any of the surfaces that contact or abut each other. For example, one surface of the engagement interface 1042 may be a superior surface of a coupling member 1032 and an inferior surface may be an inferior surface of a collar 1004. Furthermore, the engagement interface 1042 may be integrated into surfaces of existing components or may be a separate set of components that may be coupled to parts of an apparatus or device. 166 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 56 is a diagram of an example of an engagement interface 1042 that may be used in various embodiments of the present disclosure. In one embodiment, the engagement interface 1042 may include an interlocking coupling of a plurality of teeth 1052 and a plurality of valleys 1054 on each of two surfaces, inferior surface 1056 and superior surface 1058. The plurality of teeth 1052 and the plurality of valleys 1054 intermesh when the inferior surface 1056 and the superior surface 1058 abut or come into contact with each other. The plurality of teeth 1052 and plurality of valleys 1054 are sized and shaped relative to each other to intermesh. The inferior surface 1056 and superior surface 1058 may have any variety or configuration of teeth relative to valleys. Furthermore, in certain embodiments, the inferior surface 1056 and superior surface 1058 may have a single tooth and/or valley respectively. In the illustrated embodiment, the plurality of teeth 1052 and plurality of valleys 1054 have a squared surface (cross section). Alternatively, or in addition, the plurality of teeth 1052 and plurality of valleys 1054 may have triangular cross section. 165 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity In one embodiment, the engagement interface may include one or more protrusions on one or the other or both of the superior surface 1046 of the coupling member 1032 and the inferior surface 1044 of the collar 1004. Alternatively, or in addition, in certain embodiments, the engagement interface may be a hirth joint. As used herein, a “hirth coupling” or "hirth joint" refers to a type of mechanical connection named after its developer Albert Hirth. It can be used to connect two pieces of a shaft together and is characterized by tapered teeth that mesh together on the end faces of each half shaft. (Search "hirth coupling" on Wikipedia.com 2 Oct. 2021. CC-BY-SA 3.0 Modified. Accessed Nov. 15, 2021.) 164 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity In the illustrated embodiment, one or more engagement interfaces may be present. Referring still to FIGS. 54 and 55, one example engagement interface may be formed by an inferior surface 1044 of a collar 1004 and a superior surface 1046 of an inserter 1008 (e.g., a superior surface 1046 of a coupling member 1032 of the inserter 1008) and/or a superior surface of a bone fastener. Another example of an engagement interface may be formed by an inferior surface 1048 of pin extending distally from an inferior surface 1044 a collar 1004 and a superior surface 1050 near a distal end of a socket 1030 of an inserter 1008 and/or of a bone fastener. The one or more engagement interfaces 1042 constrain rotational movement of the inserter 1008 and/or the collar 1004 about an engagement axis. 163 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity In certain embodiments, one or more surfaces of the engagement member 1000 that contact one or more surfaces of the inserter 1008 and/or bone fastener may form an engagement interface. As used herein, an "interface" refers to an area, a boundary, or a place at which two separate and/or independent structures, members, apparatus, assemblies, components, and/or systems join, connect, are coupled, or meet and act on, or communicate, mechanically or electronically, with each other. In certain embodiments, "interface" may refer to a surface forming a common boundary of two bodies, spaces, structures, members, apparatus, assemblies, components, or phases. (search "interface" on Merriam-Webster.com. Merriam-Webster, 2021. Web. 15 Nov. 2021. Modified.) In certain embodiments, the term interface may be used with an adjective that identifies a type or function for the interface. For example, an engagement interface may refer to one or more structures that interact or connect to mechanically join or connect two separate structures, each connected to a side of the interface. 162 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 55 also illustrates example bolts 1034, knobs 1036, pins 1038 that couple the knobs 1036 to the bolts 1034, and springs 1040 that bias the bolts 1034 distally according to one embodiment. 161 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity In the illustrated embodiment, the shaft 1002 engages the bone fastener by way of threads 1014 that engage internal threads 1022 of a socket 1030 of the inserter 1008. Those of skill in the art will appreciate a variety of features, structures, and implementations may be used for the shaft 1002 to engage the bone fastener. For example, a pin extending laterally near the distal end 1012 may slide vertically along a channel along a wall of the socket 1030 and then seat within a horizontal section of the channel to compress the protrusion 1006 against at least a portion of the collar 1004. In certain embodiments, the inserter 1008 may include a coupling member 1032 near its proximal end. The coupling member 1032 may include the socket 1030. 160 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity In one embodiment, a user can rotate the guide 802 about the engagement axis 412 until a desired orientation of the guide 802 in relation to the fastener 804 is found. Once the desired orientation is found or obtained, the guide 802 can be secured to maintain the desired orientation. In one embodiment, to secure the guide 802 a user may engage a lock mechanism 824. Referring to FIG. 47, to engage the lock mechanism 824 a user may press the handle 826 toward the inserter 806. In the illustrated embodiment, the inserter 806 includes a threaded socket 880. A user may rotate the shaft 828 by turning the handle 826 about the engagement axis 412 in a direction that causes the shaft 828 to advance distally within the socket 880. For example, threads 834 of the shaft 828 may engage internal threads 886 of the socket 880. As the shaft 828 is rotated the shaft 828 may advance distally into the socket 880. As the shaft 828 advances, the shoulder 830 of the lock mechanism 824 pinches the guide body 814 against the inserter 806. In one embodiment, this contact provides sufficient friction to retain the guide 802 in the desired orientation. In certain embodiments, the user may tighten the lock mechanism 824 to increase the resistance to rotation by guide 802 about the engagement axis 412. 145 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity In one embodiment, the shaft 1002 engages the bone fastener by way of threads 1014 that engage internal threads 1022 of a socket 1030 of the inserter 1008 which is secured to the bone fastener. In the illustrated embodiment, rotation of the shaft 1002 in a first direction may cause the threads 1014 to advance within the internal threads 1022 of the socket 1030 and thereby draw the protrusion 1006 closer to the collar 1004. As the threads 1014 advance, the protrusion 1006 presses against at least a portion of the collar 1004 (e.g., the inferior surface 1024 may press against the superior surface 1026). In certain embodiments, this pressure (or bias) is sufficient to retain the collar 1004 and a coupled guide in a first orientation about an engagement axis. 158 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity The protrusion 1006 may extend laterally from a cross sectional diameter of the shaft 1002. The protrusion 1006 may be coupled to the shaft 1002 near the proximal end 1010. In certain embodiments, the protrusion 1006 can be a variety of shapes including rectangular, cylindrical, or the like. The protrusion 1006 includes an inferior surface 1024 configured to contact a superior surface 1026 of the collar 1004. 157 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity The collar 1004 may be coupled with or integrated with the body of a guide and may include a through passage that axially aligns with the engagement axis. In certain embodiments, the collar 1004 may include a pin that extends distally from the collar 1004. In one embodiment, the through passage may include a proximal section 1016 and a distal section 1018. The proximal section 1016 and the distal section 1018 may be cylindrical and the proximal section 1016 may have a smaller diameter than the distal section 1018. In one embodiment, the proximal section 1016 may include internal threads 1020 configured to engage threads 1014 of the shaft 1002. Alternatively, or in addition, the proximal section 1016 may include internal threads 1020 configured to engage threads (not shown) near a proximal end 1010 of the shaft 1002. The internal threads 1020 may serve to secure the shaft 1002 and/or protrusion 1006 to the collar 1004 when a guide is not coupled to an inserter 1008 and/or bone fastener. 156 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity As used herein, a "collar" refers to an apparatus, instrument, structure, device, component, system, or assembly structured, organized, configured, designed, arranged, shaped, or engineered to resemble a clothing collar in shape or use. In certain embodiments, a collar may be open or closed. Examples of a collar may include a ring or round flange that may be used to restrain motion or to hold something in place. (search "collar" on Merriam-Webster.com. Merriam-Webster, 2021. Web. 15 Nov. 2021. Modified.) As used herein, a "protrusion" refers to a structure or portion of a structure that protrudes or extends from at least one other structure such as a surface of the at least one other structure. Generally, the other structure is connected to the protrusion. 155 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 54 is a perspective view of an inserter 806 and one embodiment of an engagement member 1000 according to one embodiment, with certain components and/or details omitted for clarity. FIG. 55 is a cross section view of one embodiment of the engagement member 1000 and inserter 1008 of FIG. 54 with certain additional components and/or details included. The engagement member 1000 includes a shaft 1002, a collar 1004, a protrusion 1006, and an inserter 1008. In one embodiment, the shaft 1002 may be cylindrical and include a proximal end 1010 and a distal end 1012 (See FIG. 55). The distal end 1012, or features near the distal end 1012, engage a bone fastener. In certain embodiments, the shaft 1002 may engage the bone fastener directly. Alternatively, or in addition, the shaft 1002 may engage the bone fastener indirectly, by way of an inserter 1008 or other intermediate structure. The shaft 1002 may include threads 1014. 154 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 52 is a perspective view of a guide member 816 that includes feature 902. FIG. 52 includes pins 906 seated within the recesses 904. FIG. 53 is a top view of an inserter 806 and illustrates one example of how the pins 906 may interact with a stop member 892 of the inserter 806 to limit the range of motion of the guide 802. FIG. 53 illustrates the position of the pins 906a,b in relation to the stop member 892. For example, in a first position (shown with solid lines for the pins), pin 906a may abut the recess 896a of the inserter 806 and the projection 894 may restrict the guide 802 from further rotating about the engagement axis 412 in a counter-clockwise direction. In a second position (shown with dashed lines for the pins), pin 906b may abut the recess 896b of the inserter 806 and the projection 894b may restrict the guide 802 from further rotating about the engagement axis 412 in a clockwise direction. 153 Added by DJM 12 2021 12/2/21, 12:00 AM
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IPP-0050-US35 nextremity FIG. 50 is a bottom view of a guide 802 according to one embodiment and illustrates one example of a feature 902. In certain embodiments, the feature 902 includes one or more recesses 904a,b configured to seat and hold one or more corresponding pins 906 or dowels. In one embodiment, the recesses 904a,b may be cylindrical in shape and may be sized to accept and retain the pins 906 within the recesses 904a,b by way of a press fit. FIG. 51 is a cross section view taken along line 51-51 in FIG. 50 illustrating example recesses 904a,b that may be used for feature 902. 152 Added by DJM 12 2021 12/2/21, 12:00 AM

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