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Delete 		IPP-0050-US35 nextremity Side cuts or windows 866 communicate with the passages. Each passage receives a locking bolt 868 in axial sliding and rotating relationship. Each bolt 868 traverses one of the windows 866 exposing the portion of the bolt 868 within the window for manipulation. A knob 870 may be connected to each bolt 868, such as by pinning, to allow a user to rotate the bolt 868 about the passage axis 862 and to serve as a limit to axial travel of the bolt 868 as the knob abuts the proximal or distal margins 872, 874 of the window 866. Each bolt 868 includes a smooth cylindrical portion 876 sized to fit into a trailing portion of a stepped cylindrical cavity in one of the fastener legs. Each bolt 868 may include a threaded portion 878, distal to the smooth portion 876, sized to screw into a threaded leading portion of a stepped cavity in one of the fastener legs. 139 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity Referring to FIGS. 43-46, in one embodiment, an inserter 806 is configured for use with the fastener 804 of FIG. 39, or other FIGS. of this disclosure. The inserter 806 includes a body 854 having a distal end 856 and a proximal end 858 including a handle portion 860. The body 854 includes a pair of laterally spaced passages extending from the distal end 856 toward the proximal end 858 and each defining a passage axis 862. The passage axes 862 are angled 864 to align with cavities in the fastener 804. 138 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity In one embodiment, one or more of the sleeves 808a,b,c may include a handle or knob on a proximal end 844a,b,c. Alternatively, or in addition, the sleeves 808a,b,c may include a tapered and/or pointed end near, or at, the distal end 846a,b,c. The axial through passage, passage 842, may be sized to guide a guide wire or pin 852 (e.g., a “K-wire”) along the cross fixation insertion axis 420. Each of the one or more sleeve 808a,b,c may be translated along the axis 420 relative to the body 814 to position the distal end 846a,b,c at a desired spacing from a bone. 137 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity In certain embodiments, each of the sleeves 808a,b,c may include a passage that extends from a proximal end 844a,b,c to a distal end 846a,b,c. The passages within the sleeves 808a,b,c may be sized and configured to accept one or more implants, fasteners, tools, and/or instruments for use in deploying a fixation member. Examples of these implants, fasteners, tools, and/or instruments include but are not limited to a driver 810 coupled to a fixation member 812, a fixation member 812, a drill bit 848, depth gauge 850, a pin 852 which is one example of a temporary fastener 852 (e.g., a K-wire), or the like. FIG. 42 includes examples of implants, fasteners, tools, and/or instruments that may be used with the guide 802. Each of these example implants, fasteners, tools, and/or instruments may be canulated, in certain embodiments. 136 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity As used herein, "orientation" refers to a direction, angle, position, condition, state, or configuration of a first object, component, part, apparatus, system, or assembly relative to another object, component, part, apparatus, system, or assembly. In certain embodiments, the relative orientations are orientations of the guide 802 and/or its members in relation to the bone fastener 804. In one embodiment, the engagement member 818 couples the guide 802 to the bone fastener 804 directly. In another embodiment, the engagement member 818 couples the guide 802 to the bone fastener 804 indirectly by way of an inserter 806. In one embodiment, the engagement member 818 may be coupled to the body 814 near the distal end 822. In the illustrated embodiment, the engagement member 818 is coupled to the body 814 at the distal end 822. 121 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity In one embodiment, the guide member 816 defines a fixation axis 420 transverse to the engagement axis 412 and along which a fixation member may be guided to pass into or through a fastener aperture. The fixation axis 420 may also be referred to as a cross fixation insertion axis 420. The guide member 816 may be coupled to, connected to, and/or integrated with the guide 802 near the proximal end 820 of the guide 802. 134 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity The side surface 840 is one example of a stop that is configured to limit the plurality of relative orientations about the engagement axis to a range of angles such that deployment of the fixation member 812 will enter an aperture of the bone fastener 804. Those of skill in the art will recognize that a stop may be implemented in a variety of ways connection with, separate from, or in addition to the side surface 840 illustrated in FIG. 41. For example, the engagement member 818 may include a single stop having two ends or the engagement member 818 may include two or more stops. 133 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity The engagement member 818 may include an axial stop and a rotational stop to aid in positioning the guide 814 relative to the bone fastener 804 (and/or inserter 806). In the illustrative example of FIG. 41, the inferior surface 838 of the engagement member 818 serves as the axial stop and, in one embodiment, a side surface 840 transverse to the inferior surface 838 and formed on the guide body 814 may serve as a rotational stop. 132 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity The engagement member 818 may be configured to rotationally couple to an inserter 806. In the illustrative example of FIG. 41, the engagement member 818 includes a pin 836 extending distally from the distal end 822 of the guide body 814 and aligned with the engagement axis 412. In one embodiment, the pin 836 extends distally from an inferior surface 838 of body 814 or the engagement member 818. In one embodiment, the pin 836 is configured to engage a cavity or socket of an inserter 806 connected to the bone fastener 804. In one embodiment, the pin 836 may engage a stepped cavity or a stepped socket of an inserter 806. As described above, the stepped cavity or stepped socket may include a smooth portion and a threaded portion. 131 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity In certain embodiments, the pinching of the body between the shoulder 830 and the bone fastener 804 (and/or inserter 806) abuts one or more surfaces of the body 814 (e.g., superior surface 832) against one or more surfaces of the lock mechanism 824 to create a press fit (also referred to as a friction fit or press fit) between the surfaces. In certain embodiments, this press fit is sufficient to retain the guide member 816 at one of the plurality of relative orientations about the engagement axis 412. 130 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity In embodiments in which the socket is in the inserter 806, the shaft 828 may pass through the opening in the body 814 and engage the socket which positions at least a portion of the body between the threads 834 and the shoulder 830. In one embodiment, to operate the lock mechanism 824 a user rotates the handle 826 such that the threads 834 advance distally into the socket. As the shaft 828 advances distally within the socket, the shoulder 830 of the handle 826 pinches the body 814 towards the bone fastener 804 (and/or inserter 806). 129 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity As used herein, a “thread” or "screw thread" refers to a helical structure used to convert between rotational and linear movement or force and/or to connect or engage two structures. A screw thread can be a ridge that wraps around a cylinder in the form of a helix, referred to as a straight thread. A screw thread can also be a ridge that wraps around a cone shape, referred to as a tapered thread. A screw thread is a feature of a screw as a simple machine and also in use as a threaded fastener. A screw thread can provide one or both of the following functions: conversion of rotary motion or force into linear motion or force, and preventing or mitigating linear motion or force without corresponding rotation motion or force. In certain implementations of screw threads that convert a rotation force or torque into linear motion, or vice versa, the screw threads may be referred to as drive threads because of the drive function rotating the threads serves to extend or retract a structure linearly. External screw threads are those formed on an external surface of a structure, such as a cylinder or cone shaped structure. Internal screw threads are those formed on an internal wall or surface of a nut, substrate, or opening. The cross-sectional shape of a thread is often called its form or threadform (also spelled thread form). The thread form may be square, triangular, trapezoidal, or other shapes. The terms form and threadform can refer to other design aspects taken together (cross-sectional shape, pitch, and diameters) in addition to cross-sectional shape, but commonly refer to the standardized geometry used by the screw. Major categories of threads include machine threads, material threads, and power threads. Generally, triangular threadforms are based on an isosceles triangle. These threadforms are usually called V-threads or vee-threads because of the shape of the letter V. For 60° V-threads, the isosceles triangle is, more specifically, equilateral. For buttress threads, the triangle is scalene. The theoretical triangle shape for the thread form can be truncated to varying degrees (that is, the tip of the triangle is cut short). A V-thread in which there is no truncation (or a minuscule amount considered negligible) is called a sharp V-thread. Truncation occurs (and is codified in standards) for practical reasons. The mechanical advantage of a screw thread depends on its lead, which is the linear distance the screw travels in one revolution. In general, the lead of a screw thread may be selected so that friction is sufficient to prevent linear motion or force from being converted to rotary, that is so the screw does not slip or disengage even when linear force is applied, as long as no external rotational force is present. A “length of thread engagement” refers to a distance that one set of threads (external or internal) engages another set of one or more threads (external or internal). The tightening of a fastener's screw thread is comparable to driving a wedge into a gap until the wedge sticks fast through friction and slight elastic deformation. (Search 'screw thread' on Wikipedia.com July 16, 2021. Modified. Accessed Aug. 17, 2021.) 128 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity In one embodiment, the shaft 828 may pass through an opening (e.g., a through passage) in the body 814 as indicated by the exploded view lead lines. During use, the shaft 828 may be coaxial with the engagement axis 412. The shaft 828 is configured to engage a socket (see FIG. 44). The socket may be in an inserter 806 and/or in a bone fastener 804. In one embodiment, the shaft 828 may include threads 834. Where the threads 834 are external the socket may include corresponding internal threads. 127 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity The handle 826 facilitates a user to operating the lock mechanism 824. In one embodiment, the handle 826 is sized and configured to be grasped by a hand and/or fingers of a user. The handle 826 may include a shoulder 830. In one embodiment, the shoulder 830 contacts a superior surface 832 of the body 814 or a part of the body 814 near the distal end 822 when the lock mechanism 824 is engage or in use. 126 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity The lock mechanism 824 may include a handle 826 and a shaft 828. As used herein, a "handle" refers to a structure used to hold, control, or manipulate a device, apparatus, component, tool, or the like. A “handle” may be designed to be grasped and/or held using one or two hands of a user. 124 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity FIG. 41 is an exploded view of a guide 802 according to one embodiment of the present disclosure. Details of one example embodiment of the guide member 816 and engagement member 818 are illustrated. In one embodiment, the engagement member 818 may include a lock mechanism 824. As used herein, a "lock" or "lock mechanism" refers to an object, member, structure, component, part, apparatus, system, or assembly that either alone or in combination with other parts or components prevents, limits, impedes, is in a fixed relationship to, stops, or restricts motion or movement and/or operation of the another object, member, structure, component, part, apparatus, system, or assembly. 123 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity In certain embodiments, the engagement member 818 is configured to secure the guide member 816 and/or the guide 802 at any of the plurality of relative orientations. In one embodiment, the engagement member 818 may secure the guide member 816 at a desired relative orientation temporarily. For example, while a fixation member 812 is being deployed. In another embodiment, the engagement member 818 may secure the guide member 816 at a desired relative orientation permanently. 122 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity Various conditions may affect skeletal joints such as the deterioration, elongation, shortening, or rupture of soft tissues, cartilage, and/or bone associated with the joint and consequent laxity, pain, and/or deformity. One may desire to change the angular alignment of a bone or a portion of a bone to restore function and/or reduce pain. One may likewise desire to fuse a joint to fix the bones of the joint in a better angular alignment or reduce pain caused by motion at the joint. One may likewise desire to support a fractured bone to allow healing of the fracture to occur. One may likewise desire to support an implant on a bone. To this end, various osteotomy procedures, joint fusion procedures, fracture fixation procedures, joint resurfacing procedures, implants and instruments have been proposed. Such procedures have been performed throughout the body to make various angular adjustments in, fuse joints associated with, fuse fractures associated with, and/or resurface articular surfaces of tibia, fibula, femur, pelvis, humerus, ulna, radius, carpal, metacarpal, tarsal, metatarsal, phalangeal and other bones. 2 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity Examples of the present disclosure provide methods, implants, and instruments capable securing a bone fastener or an implant. The bone portions may be portions of the same bone as in a fracture or osteotomy. The bone portions may be portions of different bones as in arthrodesis. A bone portion may be a portion of a bone adjacent an articulating joint and the implant may be a resurfacing implant, a spacer, and/or a fusion supporting implant. 3 Added by DJM 12 2021 12/2/21, 12:00 AM
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Delete 		IPP-0050-US35 nextremity The various apparatus, devices, systems, and/or methods of the present disclosure have been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available methods, implants, and/or instruments. One general aspect of the present disclosure can include a system for deploying a fixation member into an aperture of a bone fastener. The system may include a guide that may include a body having a proximal end and a distal end. The guide may also include a guide member coupled to the body near the proximal end, where the guide member is configured to guide placement of the fixation member to secure the bone fastener. The guide may also include an engagement member coupled to the body near the distal end, where the engagement member is configured to engage the bone fastener such that the guide member is rotatable, relative to the bone fastener, about an engagement axis to a plurality of relative orientations. The engagement member is configured to secure the guide member at any of the plurality of relative orientations about the engagement axis. 4 Added by DJM 12 2021 12/2/21, 12:00 AM

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