Universal Broach System for Humeral Implants

Abstract

A broach (800) for preparing bone to receive anchors for a prosthesis includes a body (802) having a proximal surface (816) and a socket (810) extending therein, and an anchor component extending from the body, the anchor component including spokes (804A-F) extending laterally from the body and spoke tips extending proximally from the spokes above an upper surface. The system includes a distal broach component including the broach body, the sockets extending within the upper surface, and a plurality of cutting spokes extending radially from the broach body, separated by a spacing pattern; and a proximal broach component (801) including a main body (820) configured to attach to the upper surface of the broach body and a plurality of spacer spokes (824A-F) separated by a spacing pattern and extending radially from the spacer body.

Description

[Technical Field]

[0001] (Priority Claim) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 421,829, filed November 2, 2022, which also claims the benefit of U.S. Provisional Patent Application No. 63 / 471,883, filed June 8, 2023, the benefit of which is claimed herein and each of which is incorporated by reference in its entirety.

[0002] The present disclosure is directed generally, but not exclusively, to systems, devices, and methods for performing medical procedures such as partial and total shoulder arthroplasty. More particularly, but not exclusively, the present disclosure is directed to medical instruments used to perform reverse shoulder arthroplasty, such as broaches used to shape bone to accommodate bone anchors. [Background technology]

[0003] The shoulder joint includes the humerus and scapula, which cooperate to provide a range of motion of the humerus relative to the scapula during movement of the human arm. Specifically, the proximal end of the humerus, including the humeral head, is positioned adjacent to the glenoid cavity of the scapula and can move relative to the glenoid cavity to provide a range of motion of the humerus relative to the scapula.

[0004] When the shoulder joint becomes painful or otherwise damaged during use, a joint replacement procedure, such as a partial or total shoulder arthroplasty, becomes necessary or desirable. For example, the shoulder joint may become damaged due to osteoarthritis, which can expose bare bone within the shoulder joint as a result of progressive wear and tear of the cartilage. In such situations, it is often necessary or desirable to perform a partial or total shoulder arthroplasty to reconstruct a portion of the shoulder joint, thereby alleviating pain and increasing the range of motion of the humerus.

[0005] In performing a total shoulder arthroplasty, a surgeon resects a portion of the proximal end of the humerus, e.g., the humeral head, that is to be received by the glenoid cavity. Once the proximal end of the humerus has been resected, the surgeon can then ream the humerus to access the humeral canal. By providing access to the humeral canal, the surgeon can insert an anchor component, e.g., a stemmed prosthesis, e.g., a prosthetic humeral head attached to the stemmed anchor component, into the humeral canal. A hemispherical prosthetic humeral head can then be attached to the proximal end of the anchor component so that the prosthetic humeral head replaces the resected portion of the humerus. If desired, the surgeon can similarly replace a portion of the glenoid cavity with a prosthetic bearing component to provide a bearing surface against which the prosthetic humeral head can be configured to articulate. In a reverse shoulder arthroplasty, a prosthetic humeral head component is attached to the scapula, and a prosthetic bearing component is attached to the humerus. Once shoulder arthroplasty is completed, pain is typically relieved and the patient is provided with an increased range of motion in the shoulder joint.

[0006] While conventional shoulder prostheses used during shoulder arthroplasty adequately provide patients with increased range of motion, conventional shoulder prostheses typically require the insertion of a stem, e.g., a stemmed prosthesis or a stemmed anchor, into the humeral canal of the humerus, which increases the overall weight, size, and cost of the humeral component. Furthermore, inserting the stem of the stemmed prosthesis into the humeral canal makes the surgical procedure somewhat complicated, as the surgeon must first resect the humeral head of the humerus and then perform broaching and / or reaming operations on the humeral canal before inserting the stem of the stemmed prosthesis into the humeral canal. Therefore, care must be taken to avoid excessively compromising the integrity of the humerus and creating additional weakness due to bone dislodgement. As the complexity of joint replacement surgery increases, the surgeon's time required to perform the procedure also increases, thereby increasing the overall cost of the procedure. Finally, insertion of the stem into the humerus may result in additional bone removal, which can increase trauma and post-operative pain.

[0007] Examples of humeral broaches are described in U.S. Patent No. 5,629,999 to Hatzidakis, entitled "Shoulder Arthroplasty Implant System," U.S. Patent No. 5,629,999 to Reubelt, entitled "Femoral and Humeral Stem Geometry and Implantation Method for Orthopedic Joint Reconstruction," and U.S. Patent No. 5,629,999 to Terrill, entitled "Keeled Glenoid Implant." [Prior art documents] [Patent documents]

[0008] [Patent Document 1] US Patent Application Publication No. 2020 / 0315807 [Patent Document 2] International Publication No. 2007 / 109340 [Patent Document 3] U.S. Patent Application Publication No. 2021 / 0030552 Summary of the Invention [Problem to be solved by the invention]

[0009] The present inventors have recognized that, among other problems, a problem to be solved in preparing the humerus of a shoulder joint to receive prosthetic components is the difficulty of assessing and subsequently preparing the humerus for both inlay and onlay anchor components. Inlay and onlay components can be used in stemless humeral implants, where bone material is preserved by avoiding the use of a stem. The subject matter of the present application is applicable to both stemmed and stemless humeral prosthetic components, as well as other components that may have different thicknesses and configurations. A typical shoulder prosthesis includes an anchor component, such as a stemmed anchor component discussed above or a stemless anchor component discussed below, that is affixed to a resected bone surface to which a prosthetic humeral head component or a prosthetic bearing component for anatomic shoulder arthroplasty and reverse shoulder arthroplasty, respectively, is then attached. However, several factors can influence whether an inlay or onlay anchor component is used, such as how much bone should be removed during the resection to remove diseased or damaged bone, as well as other factors such as surgeon preference. Additionally, shoulder joint laxity, such as tension within the joint caused by ligaments and other soft tissues, is an additional consideration. With an onlay anchor component, a tray housing a prosthetic component, such as a prosthetic humeral head or prosthetic bearing, is flush with the resected bone surface. With an inlay anchor component, a tray housing a prosthetic component, such as a prosthetic humeral head or prosthetic bearing, is recessed into the resected bone surface. Therefore, the humerus is modified differently to prepare for an inlay anchor component than for an onlay anchor component. Specifically, the resected surface of the humerus is reamed to accommodate the inlay anchor component. Therefore, an onlay anchor component typically occupies more space within the joint than an inlay anchor component.However, due to joint laxity, resection thickness, and surgeon preference, it can be difficult to assess in advance whether an inlay or onlay anchor component will provide the best outcome for the patient, e.g., restoring the joint to anatomic tension.

[0010] The subject matter can provide a solution to these and other problems by providing a broaching system that allows for evaluation of the shoulder joint to determine whether an inlay anchor component is desired, for example, before reaming of the humerus. After making resections compatible with both inlay and onlay anchor components, a general-purpose broach can be implanted into the resected proximal end of the humerus. The general-purpose broach can function as a trial anchor component to evaluate laxity of the shoulder joint. Specifically, a spacer can be attached to the implanted general-purpose broach to evaluate joint laxity. The spacer can be engaged with features engaged to an implanted anchor component, such as a prosthetic glenoid attached to the scapula or the anatomical glenoid cavity of the scapula. The spacer can be configured to occupy an amount of space within the shoulder joint equivalent to that of the completed inlay anchor component, i.e., the inlay and its attached prosthetic bearing component. Therefore, if the spacer is loose within the joint, an onlay anchor component can be used because it is thicker (occupies more space within the joint) than an inlay anchor component. However, if the spacer is tight or not fitted within the joint, an inlay anchor component can be used because it is thinner (taking up less space within the joint) than an onlay anchor component. If it is determined that an onlay anchor component should be used, no further bone modification is performed. If it is determined that an inlay anchor component should be used, a reaming guide can be attached to the already implanted general-purpose broach to guide reaming of the resected surface of the humerus to shape the bone material above the general-purpose broach to accommodate the inlay anchor component. In this way, a single general-purpose broach can be implanted using a common procedure for both inlay and onlay anchor components.

[0011] In one embodiment, a broach for preparing bone to receive an anchor for a prosthetic implant can include a body including an upper surface and a socket extending into the upper surface, and a first anchoring component extending from the body including spokes extending laterally from the body and spoke tips extending proximally from the spokes above the upper surface.

[0012] In an additional embodiment, a system for preparing bone to accommodate a prosthetic implant can include a broach including a body including a socket extending into an upper surface of the body and an anchoring component extending from the body; a spacer including an attachment component configured to attach to the socket and a spacer body attached to the attachment component; an onlay implant including a second attachment component configured to attach to the socket, a planar base attached to the second attachment component and a first bearing component attached to the planar base; and an inlay implant including a third attachment mechanism configured to attach to the socket, a bowl-shaped base attached to the third attachment mechanism and the second bearing component attached to the bowl-shaped base, wherein the spacer body has a thickness equal to a maximum gap thickness of the inlay implant.

[0013] In another embodiment, a method of implanting a prosthetic component into bone includes inserting a broach into a resected surface of a first bone of a joint, attaching a spacer to the broach, positioning the spacer in a space between the first and second bones of the joint while attached to the broach, determining the use of an inlate or onlate ray based on the laxity of the joint with the spacer inserted therein, attaching the onlate ray to the broach if the joint is loose, and attaching the inlate ray to the broach if the joint is tight.

[0014] A system for preparing bone to receive a prosthetic implant anchor can include a first distal broach component including a first broach body, a first socket extending into a first upper surface of the first broach body, and a first plurality of cutting spokes extending radially from the first broach body, each of the first plurality of cutting spokes separated by a spacing pattern; and a proximal broach component including a spacer body configured to attach to the first upper surface of the first broach body, and a plurality of spacer spokes extending radially from the spacer body, each of the plurality of spacer spokes separated by a spacing pattern.

[0015] A method for implanting a prosthetic component into a bone may include resecting a surface of a first bone of a joint, inserting a spacer paddle to assess loosening of the first bone of the joint, assembling a proximal spacer body with a distal broach body to form a broach assembly, inserting the broach assembly into the resected surface of the first bone of the joint, determining to use an inlate lay or an onlate lay based on the assessed loosening of the first bone of the joint, and attaching the onlate lay to the broach assembly if the joint is loose, and attaching the inlate lay to the distal broach body if the joint is tight. [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 is a perspective view of a general purpose broach of the present disclosure configured for broaching the humerus for inlay and on-lay configurations. [Figure 2A] FIG. 2A is a side view of the general purpose broach of FIG. 1 implanted in the humerus for on-late lay. [Figure 2B] FIG. 2B is a cross-sectional view of the general purpose broach of FIG. 2A with an on-rate lay and bearing component attached. [Figure 3A] 3A is a side view of the general purpose broach of FIG. 1 implanted in the humerus for inlay purposes. [Figure 3B] FIG. 3B is a cross-sectional view of the general purpose broach of FIG. 3A with an inlay and bearing component attached. [Figure 4A] FIG. 4A is a side view of the general-purpose broach of FIG. 1 attached to an inserter in a contracted state for insertion into bone. [Figure 4B] FIG. 4B is a cross-sectional view of the inserter and general-purpose broach of FIG. 4A. [Figure 5A] FIG. 5A is a side view of the general purpose broach and inserter of FIG. 4A in an extended position to drive the general purpose broach further into the bone. [Figure 5B] FIG. 5B is a cross-sectional view of the inserter and general-purpose broach of FIG. 5A. [Figure 6A] FIG. 6A is a side view of the general purpose broach of FIG. 1 inserted into the humerus while attached to a spacer. [Figure 6B] FIG. 6B is a top perspective view of the spacer of FIG. 6A showing the articular surface for engagement with a prosthetic head implant. [Figure 6C] FIG. 6C is a side cross-sectional view of the spacer of FIG. 6A showing a mounting portion for a general-purpose broach. [Figure 7] 7 is a perspective view of the general-purpose broach of FIG. 1 inserted into bone, with the reaming guide shown exploded therefrom. [Figure 8A] 8A is a side view of a reaming guide attached to the general-purpose broach of FIG. 7. FIG. [Figure 8B] 8B is a cross-sectional view of the reaming guide and general-purpose broach of FIG. 8A. [Figure 9] FIG. 9 is a perspective view of a reamer positioned on the reaming guide of FIGS. 8A and 8B. [Figure 10A] 10A is a cross-sectional view of the reamer and reaming guide of FIG. 9 with the reamer positioned above the humerus. [Figure 10B] 10B is a cross-sectional view of the reamer and reaming guide of FIG. 9 with the reamer extended into the humerus. [Figure 11A]FIG. 11A is a top view of the general purpose broach of FIG. 1 showing various features that facilitate functioning with a ream guide to perform reaming for in-lay construction. [Figure 11B] FIG. 11B is a side cross-sectional view of the general purpose broach of FIG. 1 showing various features that facilitate functioning with a ream guide to perform reaming for an inlay construction. [Figure 12] FIG. 12 is a diagram illustrating steps of the method of the present disclosure relating to implantation of an inlay or on-lay configuration using a general purpose broach of the present disclosure. [Figure 13] FIG. 13 is a schematic illustration of a shoulder joint configured to receive a total shoulder replacement in a reverse shoulder configuration in one embodiment of the present disclosure. [Figure 14A] FIG. 14A is a perspective view of a universal broach assembly including a universal broach proximal body and a universal broach distal body. [Figure 14B] FIG. 14B is a perspective view of a universal broach assembly including a universal broach proximal body and a universal broach distal body. [Figure 15] FIG. 15 is a side view of the universal broach assembly of FIGS. 14A and 14B. [Figure 16] FIG. 16 is a top view of the universal broach assembly of FIGS. 14A and 14B. [Figure 17A] FIG. 17A is a perspective view of a universal broach proximal body exploded from a universal broach distal body. [Figure 17B] FIG. 17B is a perspective view of the universal broach proximal body exploded from the universal broach distal body. [Figure 18] FIG. 18 is a top perspective view of a universal broach distal body of the present disclosure. [Figure 19] FIG. 19 is a bottom perspective view of a universal broach distal body of the present disclosure. [Figure 20] FIG. 20 is a side view of the universal broach distal body of FIGS. [Figure 21] FIG. 21 is a top view of the universal broach distal body of FIGS. [Figure 22] FIG. 22 is a top perspective view of a universal broach proximal body of the present disclosure. [Figure 23] FIG. 23 is a bottom perspective view of a universal broach proximal body of the present disclosure. [Figure 24] FIG. 24 is a side view of the universal broach proximal body of FIGS. 22 and 23. FIG. [Figure 25] FIG. 25 is a top view of the universal broach proximal body of FIGS. 22 and 23. FIG. [Figure 26A] FIG. 26A is a side view of a general-purpose broach proximal body and a general-purpose broach distal body of a first size. [Figure 26B] FIG. 26B is a top view of the proximal and distal bodies of the general-purpose broach of FIG. 26A inserted into the resected humerus. [Figure 27A] FIG. 27A is a side view of a second size universal broach proximal body and a universal broach distal body. [Figure 27B] FIG. 27B is a top view of the proximal and distal bodies of the general-purpose broach of FIG. 27A inserted into the resected humerus. [Figure 28] FIG. 28 is a side view of a removal tool suitable for use with the universal broach assembly of FIGS. 14A-27B. [Figure 29] FIG. 29 is a perspective view of a removal tool attached to a universal broach assembly. [Figure 30] FIG. 30 is a perspective view of a removal tool advanced to separate the universal broach proximal body from the universal broach distal body. [Figure 31] FIG. 31 is a perspective view of a universal broach proximal body separated from a universal broach distal body and a removal tool. [Figure 32] FIG. 32 is a cross-sectional view of the universal broach proximal body and the universal broach distal body of FIGS. 14A-27B mounted on an insertion tool. [Figure 33] 33 is a side view of the insertion tool of FIG. 21 actuated to drive the universal broach assembly into bone. [Figure 34]FIG. 34 is a diagram illustrating steps of the method of the present disclosure relating to implantation of an inlay or on-lay configuration using the universal broach proximal body and universal broach distal body of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0017] FIG. 1 is a perspective view of a general purpose broach 100 of the present disclosure configured for broaching a humerus, such as humerus 200 of FIG. 2A , for inlay and on-lay configurations. General purpose broach 100 may include a main body 102 and spokes 104A through 104F. Main body 102 may include a socket 105. Spoke 104A may include a blade 106A and a wing 108A. Spoke 104B may include a blade 106B and a wing 108B. Spoke 104C may include a blade 106C and a wing 108C. Spoke 104D may include a blade 106D. Spoke 104E may include a blade 106E and a wing 108E. Spoke 104F may include a blade 106F.

[0018] The general-purpose broach 100 can be configured to be inserted into bone so that the spokes 104A-104F can function to cut the bone to form a shell 140 (see FIG. 3A ) or template that can accommodate an implantable anchor component after the general-purpose broach 100 is removed. The main body 102 and spokes 104A-104F can have the same or similar shape as an anchor component that is shaped to be implanted into bone to provide a secure attachment to the bone material, such as a tight fit that prevents rotation and backout. A prosthetic component, such as a prosthetic humeral head component or a prosthetic bearing component, can then be attached to the implantable anchor component. Prosthetic components of different configurations can be attached to the same anchor component. The general-purpose broach 100 can be shaped to provide for the insertion of a single anchor component that can accommodate prosthetic components of different shapes. In particular, two different types of trays, namely, inlate trays and onlate trays, can be used with anchor components to hold various prosthetic bearing components of different thicknesses. The universal broach 100 can be attached to the on-rate lay 206 and prosthetic bearing component 230 of Figures 2A and 2B and the in-rate lay 250 and prosthetic bearing component 270 of Figures 3A and 3B.

[0019] The general-purpose broach 100 can be used to couple to a trial tray so that the surgeon can determine whether an inlay or onlay lay is needed or desired before constructing the final implantable device. An inserter 300 (see FIGS. 4A-5B) can be used to insert the general-purpose broach 100 into the bone. A spacer 400 (see FIGS. 6A-6C) can be attached to the general-purpose broach 100 to assist the surgeon in determining whether an inlay or onlay lay will be used. A reaming guide 500 (see FIG. 7) can be attached to the general-purpose broach 100 to allow a reamer 520 (see FIG. 9) to ream the bone (e.g., the humerus 200 of FIG. 2A) to accommodate the inlay. Thus, the general-purpose broach 100 can be used to implant humeral head or bearing components in both inlay and onlay configurations, and only one broaching operation can be performed, with the general-purpose broach 100 remaining in place until the final prosthetic construct is determined and prepared for implantation. Thus, multiple steps of inserting various components into the bone or multiple broaching operations to determine the final prosthetic construct can be avoided.

[0020] Figure 2A is a side view of the general-purpose broach 100 of Figure 1 implanted in a humerus 200 for an on-rate ray 206 of Figure 2B. Figure 2B is a cross-sectional view of the general-purpose broach 100 of Figure 2A with an on-rate ray 206 attached. Figures 2A and 2B will be discussed simultaneously.

[0021] The humerus 200 can include a resected surface 202. The on-rate ray 206 can include a stem 210, a base 212, and a wall 214. The stem 210 can include a mounting portion 216 including arms 218A and 218B. The base 212 and the wall 214 can form a socket 220. The on-rate ray 206 can be attached to a prosthetic bearing component 230. The prosthetic bearing component 230 can include a base 232, a mounting portion 234, and a cup 236.

[0022] In an onlay procedure, the onlay 206 is attached to the general purpose broach 100 so that the base 212 is flush with the resected surface 202. Thus, the onlay 206 resides on the lateral or superior surface of the humerus 200.

[0023] The general-purpose broach 100 can be implanted into the humerus 200 up to a distance D1 below the resected surface 202. Specifically, the superior or proximal-most surfaces of the blades 106A-106F can be positioned a distance D1 below the resected surface 202. The attachment portion 216 of the stem 210 can then be inserted into the socket 105 of the general-purpose broach 100. The attachment portion 216 can provide a means for maintaining the on-rate ray 206 engaged with the general-purpose broach 100. The arms 218A and 218B can flex to engage the socket 105 and maintain a tight fit. However, to facilitate removal of the on-rate ray 206 from the general-purpose broach 100, the arms 218A-218B can be deflected, such as by tilting the on-rate ray 206.

[0024] Thus, the prosthetic bearing component 230 can be positioned above the universal broach 100 and the resected surface 202. More specifically, the bottom surface of the cup 236 can be positioned a distance D2 above the top surfaces of the spokes 104A-104F. The distance D2 can be determined by the thickness T1 of the base 212 of the on-rate ray 206 and the thickness T2 of the base 232 of the prosthetic bearing component 230. In some embodiments, the on-rate ray 206 and the prosthetic bearing component 230 can be provided in different sizes, where the thicknesses T1 and T2 can be different. That is, the thickness T1 can be two different thicknesses, and the thickness T2 can be two different thicknesses. Thus, the distance D2 can have four different lengths. In each configuration, the base 232 of the on-rate ray 206 and the prosthetic bearing component 230 can all be positioned above the resected surface 202.

[0025] Figure 3A is a side view of the general purpose broach 100 of Figure 1 implanted in the humerus 200 for the inrate-lay 250 of Figure 3B. Figure 3B is a cross-sectional view of the general purpose broach 100 of Figure 3A with the inrate-lay 250 attached. Figures 3A and 3B will be discussed simultaneously.

[0026] The humerus 200 may include a resected surface 202 and a reamed recess 204. The inlate lay 250 may include a stem 252, a base 254, and a wall 256. The stem 252 may include a mounting portion 258 including arms 260A and 260B. The base 254 and the wall 256 may form a socket 262. The inlate lay 250 may be coupled to a prosthetic bearing component 270. The prosthetic bearing component 270 may include a base 272, a mounting portion 274, and a cup 276.

[0027] In the inlay procedure, the inlay 250 is attached to the general purpose broach 100 so that the base 254 is recessed into the resected surface 202. The inlay 250 thus resides medially or internally within the humerus 200 within the recess 204. The recess 204 can be formed using a reamer 520 of Figures 9A-10B.

[0028] The general-purpose broach 100 can be implanted into the humerus 200 up to a distance D1 below the resected surface 202. Specifically, the superior or proximal-most surfaces of the blades 106A-106F can be positioned a distance D1 below the resected surface 202. The attachment portion 258 of the stem 252 can then be inserted into the socket 105 of the general-purpose broach 100. The attachment portion 258 can provide a means for maintaining the inlate lay 250 engaged with the general-purpose broach 100. The arms 260A and 260B can flex to engage the socket 105 and maintain a tight fit. However, to facilitate removal of the inlate lay 250 from the general-purpose broach 100, the arms 260A-260B can be deflected, such as by tilting the inlate lay 250.

[0029] Thus, the prosthetic bearing component 270 can be positioned above the universal broach 100. More specifically, the bottom surface of the cup 276 can be positioned a distance D3 above the upper surfaces of the spokes 104A-104F. The distance D3 can be determined by the thickness T3 of the base 254 of the inrate-lay 250 and the thickness T4 of the base 272 of the prosthetic bearing component 270. In some embodiments, the inrate-lay 250 and the prosthetic bearing component 270 can be provided in different sizes, where the thicknesses T3 and T4 can be different. That is, the thickness T3 can be two different thicknesses, and the thickness T4 can be two different thicknesses. Thus, the distance D4 can have four different lengths. In each configuration, the base 254 of the inrate-lay 250 can be recessed within the resected surface 202, but the bottom surface of the cup 276 can be positioned above or below the resected surface 202, depending on the thicknesses selected for T3 and T4.

[0030] In some embodiments, prosthetic bearing component 270 and prosthetic bearing component 230 may be interchangeable, providing fewer components for the universal broaching system of the present application. In some embodiments, thickness T3 may be X mm thick or X + 5 mm thick. In some embodiments, thickness T1 may be Y mm thick or X + 5 mm thick. In some embodiments, thicknesses T2 and T4 may be Z mm thick and Z + 3 mm thick. In some embodiments, the X + Z combination may position cup 276 1.5 mm below resected surface 202 in a minimum configuration. Therefore, the bottom of cup 276 may be located 6.5 mm above resected surface 202 in a maximum configuration. In some embodiments, the Y + Z combination may position cup 236 4.5 mm above resected surface 202. Therefore, the bottom of cup 236 may be located 12.5 mm above resected surface 202 in a maximum configuration.

[0031] 2B and 3B, the generic broach 100 is implanted to the same depth D1 for the on-rate ray 206 and the in-rate ray 250. Therefore, the same procedure can be used to insert the generic broach 100 for both the on-rate ray 206 and the in-rate ray 250. However, the on-rate ray 206 and the in-rate ray 250 are implanted after the humerus 200 has been modified differently. Specifically, the in-rate ray 250 requires reaming of the resected surface 202 to allow the in-rate ray 250 to be recessed into the humerus 200. However, due to, for example, the condition of the soft tissues, e.g., ligaments, etc., it is not always clear to the surgeon until after a joint trial whether the on-rate ray 206 or the in-rate ray 250 will provide a better treatment outcome for the patient, such as in an anatomically tensioned joint. The general-purpose broach 100 allows for assessment of joint loosening or tightness prior to reaming of the humerus 200 so that it can be determined whether the in-lay 206 will provide sufficient tensioning of the joint without reaming, or whether the in-lay 250 can be used to create the reamed recess 204 with the additional step of reaming the bone 202. In particular, the general-purpose broach 100 can be inserted into the resected surface 202 and then attached to the spacer 400 to assess laxity of the shoulder joint.

[0032] Figure 4A is a side view of the inserter 300 attached to the general-purpose broach 100 of Figure 1 in a contracted state. Figure 4B is a cross-sectional view of the inserter 300 and general-purpose broach 100 of Figure 4A. Figure 5A is a side view of the inserter 300 of Figure 4A in an extended state for impacting the general-purpose broach 100 into the humerus 200. Figure 5B is a cross-sectional view of the inserter 300 and general-purpose broach 100 of Figure 5A. Figures 4A through 5B will be discussed simultaneously.

[0033] The inserter 300 may include a base 302 and a handle 304. The handle 304 may be slidable within a channel 306 in the base 302 to drive the universal broach 100 into bone material. The base 302 may include a channel 306, a plate 308, arms 310A and 310B, a shaft 312, a lock 314, and a knob 316. The handle 304 may include a shaft 318, a mounting portion 320, and a knob 322.

[0034] The humerus 200 can be resected to remove the humeral head and create a resected surface 202. A surgeon can measure the cross-sectional area or diameter of the resected surface 202 to determine the appropriate size, e.g., small, medium, or large, of the prosthetic component to be implanted within the humerus 200. A sizer can be used to place a pin in the center or central portion of the resected surface 202.

[0035] A pin can be placed in the center of the resected surface 202. A reamer can then be used to remove a small cylindrical portion of bone material around the pin to facilitate insertion of the general purpose broach 100. In some embodiments, the diameter of the reamer can correspond to the diameter of the main body 102 of the general purpose broach 100. For example, FIGS. 2B and 6C show a channel 130 formed in the humerus 200 surrounding the stem 210.

[0036] The universal broach 100 can be loaded into the inserter 300 by inserting the mounting portion 320 into the socket 105 of the main body 102 on the universal broach 100. An extension 321 spaces the mounting portion 320 from the bottom surface of the shaft 318. The plate 308 can include an opening 324 into which the universal broach 100 can be inserted and coupled to the mounting portion 320. A lock 314 can be used to secure the shaft 318 of the handle 304 within the channel 306 of the shaft 312 of the base 302. In an embodiment, the shaft 318 can be spring-loaded within the channel 306, and the lock 314 can secure the shaft 318 with the activation spring in a compressed state. In the locked position, the blades 106A-106F of the universal broach 100 can protrude beyond the plate 308. A surgeon can manually align blades 106A-106F within the confines of resection surface 202, for example, in channel 130. The surgeon can then push blades 106A-106F into the bone material below resection surface 202 until plate 308 contacts resection surface 202, as shown in FIGS. 4A and 4B. Lock 314 can be released to allow shaft 318 to slide within channel 306. As shown in FIGS. 5A and 5B, the surgeon can grasp handle 304 with one hand and depress knob 322 to advance shaft 318 along channel 306, extending attachment portion 320 beyond plate 308 and moving general-purpose broach 100 outside channel 306 and further below resection surface 202 into the bone material. In some embodiments, lock 314 can release the compression of the activation spring, allowing shaft 318 of handle 304 to self-activate and drive the general-purpose broach into the bone material. Shaft 318 can be advanced so that the bottom of shaft 318 can be flush with the bottom of plate 308 against resected surface 202, with attachment portion 320 extending into the bone material. Inserter 300 can then be removed from general-purpose broach 100 by removing attachment portion 320 from socket 105.Thus, the general-purpose broach 100 can be left in the humerus 200, as shown in FIG. 2A , with the upper surfaces of the blades 106A-106F positioned a distance D1 below the resected surface. Using the inserter 300, the general-purpose broach 100 can be inserted a predetermined amount below the resected surface 202, which may correlate to the amount that the attachment portion 216 of the on-rate lay 206 and the attachment portion 258 of the in-rate lay 250 are configured to extend into the bone. The inserter 300 provides a repeatable insertion process, with a repeatable length for the distance D1 each time the shaft 318 is actuated, as described above.

[0037] Figure 6A is a side view of a spacer 400 attached to a general-purpose broach 100 inserted into the humerus 200. The spacer 400 may include a head 402 and a handle 404. Figure 6B is a top perspective view of the spacer 400 of Figure 6A, showing an articular surface 406 for engaging a prosthetic head implant. Figure 6C is a side cross-sectional view of the spacer 400 of Figure 6A, showing a mounting portion 408 for the general-purpose broach 100. Figures 6A through 6C are discussed simultaneously.

[0038] After implanting the general-purpose broach 100 in the humerus 200 using the inserter 300, a spacer 400 can be attached to the general-purpose broach 100. The attachment portion 408 can be inserted into the socket 105 of the general-purpose broach 100. As can be seen in FIG. 6C , the attachment portion 408 can include arms 410A and 410B. The attachment portion 408 provides a means for maintaining the spacer 400 in engagement with the general-purpose broach 100. The arms 410A and 410B can bend to engage with the socket 105 to maintain a tight fit. However, the arms 410A-410B can be deflected, such as by an angled spacer 400, to facilitate removal of the spacer 400 from the general-purpose broach 100. A handle 404 can be attached to the head 402 to facilitate movement of the spacer 400 within the joint, and the spacer 400 can include a spacer paddle.

[0039] The general-purpose broach 100 can be used to assess ligament tension, e.g., laxity, within a joint, such as the shoulder joint 700 of FIG. 13. For example, the general-purpose broach 100 can be positioned adjacent to the scapula while inserted into the humerus 200 and attached to the spacer 400. By way of example, the general-purpose broach 100 can be implanted into the humerus 704 (see FIG. 13), and the spacer 400 can be positioned adjacent to a prosthetic glenoid 706 implanted within the scapula 702. Soft tissue, such as ligaments, can then pull the humerus 704 toward the scapula 702, thereby engaging the spacer 400 with the prosthetic glenoid 706, when the soft tissue allows the spacer 400 to fit within a space, such as gap G in FIG. 13.

[0040] The spacer 400 can be designed to provide the maximum offset provided by the inlay 250 plus the prosthetic bearing component 270. The maximum offset provided by the inlay 250 and the prosthetic bearing component 270 can be provided by using a combination of the inlay 250 configured to have a maximum thickness of T3 and the prosthetic bearing component 270 configured to have a maximum thickness of T4. The maximum combination of thicknesses T3 and T4 results in a distance D3 equal to the distance D4 of the spacer 400. When the universal broach 100 is attached to the spacer 400, the distance D4 can be measured from the bottom of the articular surface 406 to the top surface of the spokes 104A through 104F. Therefore, the distance D4 can be configured to be equal to the distance D3 for the maximum thickness combination of T3 and T4. Distance D2 minus distance D1 can be considered the gap height provided by the inlay 206 and the prosthetic bearing component 230. Distance D3 minus distance D1 can be considered the gap height provided by inlay 250 and prosthetic bearing component 270.

[0041] Therefore, if the spacer 400 is loose within the joint, it is an indication that it is desirable to use an on-rate lay 206 and prosthetic bearing component 230 that provides a greater amount of offset than the in-rate lay 250 and prosthetic bearing component 270. A loose spacer 400 within the joint may mean that no combination of in-rate lay 250 and prosthetic bearing component 270 can be assembled to eliminate the looseness in the joint. Therefore, an on-rate lay 206 and prosthetic bearing component 230 combination that can have a combination of thicknesses T1 and T2 that is greater than the distance D4 minus D1 can be used to fill the joint. However, if the spacer 400 is tight within the joint, or does not fit within the joint, it is an indication that it is desirable to use the in-rate lay 250 after reaming the resected surface 202 to remove additional bone material, if necessary depending on the combination of in-lay thicknesses T3 and T4. The combination of the inlay 250 and prosthetic bearing component 270 can be made to have thicknesses T3 and T4 that are less than the distance D4 minus D1 that fits within the joint.

[0042] After the laxity of the joint is determined using the spacer 400, the spacer 400 can be removed from the general-purpose broach 100, which can be left in the joint. The general-purpose broach 100 can be used to trial the joint, whether an inlay or onlay implant trial, such as those shown in FIGS. 2A-3B, is determined. If the onlay ray 206 is used, the resected surface 202 can be left alone. However, if the inlay ray 250 is used, the resected surface 202 can be reamed using the reamer 520.

[0043] Figure 7 is a perspective view of the general-purpose broach 100 of Figure 1 inserted into the humerus 200, with the reaming guide 500 shown exploded therefrom. The reaming guide 500 may include a shaft 502 and a mounting portion 504. The mounting portion 504 may include arms 506A and 506B. The shaft 502 may include a tapered tip 508. Figure 8A is a side view of the reaming guide 500 attached to the general-purpose broach 100 of Figure 7. Figure 8B is a cross-sectional view of the reaming guide 500 and general-purpose broach 100 of Figure 8A. Figures 7 through 8B will be discussed simultaneously.

[0044] The reaming guide 500 may provide rails or pegs on which a reaming device, such as a reamer 520, can be positioned and slid up and down. The tapered tip 508 may include a narrower cross-section compared to the shaft 502, which may facilitate insertion of the reaming guide 500 into a socket 530 of the reamer 520, such as the socket 530 of FIG. 10A . The diameter of the shaft 502 between the tapered tip 508 and the mounting portion 504 may be slightly smaller than the socket 530 to maintain the reamer 520 centered on the reaming guide 500. The mounting portion 504 may provide a means for maintaining the reaming guide 500 in engagement with the general-purpose broach 100. The arms 506A and 506B may flex to engage the socket 105 and maintain a tight fit. However, the arms 506A to 506B may be deflected, for example, by tilting the reaming guide 500 to facilitate removal of the reaming guide 500 from the general purpose broach 100.

[0045] Figure 9 is a perspective view of a reamer 520 positioned on the reaming guide 500 of Figures 8A and 8B. The reamer 520 may include a handle 522 and a reaming head 524. The handle 522 may include a shaft 526, a base 528, a socket 530 (see Figures 10A and 10B), and a coupler 532. The reaming head 524 may include a ring 534, spokes 536A to 536E, and cutting elements 538A to 538E. The reamer 520 may be reciprocated along the reaming guide 500 and rotated about the axis of the reaming guide 500 to remove bone material from the humerus 200.

[0046] Figure 10A is a cross-sectional view of the reamer 520 and reaming guide 500 of Figure 9 with the reamer 520 positioned above the humerus 200. Figure 10B is a cross-sectional view of the reamer 520 and reaming guide 500 of Figure 9 with the reamer 520 positioned within the humerus 200. Figures 10A and 10B will be discussed simultaneously.

[0047] The reamer 520 can be positioned on top of the reaming guide 500 so that the socket 530 is aligned with the tapered tip 508. The reamer 520 can be pushed down onto the reaming guide 500 until the cutting elements 538A-538D contact the resected surface 202. The reamer 520 can be rotated about the axis of the shaft 502, causing the cutting elements 538A-538D to remove bone material. The reamer 520 can be advanced further toward the humerus 200 until the ring 534 contacts the resected surface 202. Once the ring 534 contacts the resected surface 202, the base 528 of the reamer 520 can engage with the general-purpose broach 100. Specifically, the base 528 can engage with the socket 105. In this manner, the diameter of the base 528 can be approximately the same as the main body 102, allowing the reamer 520 to rest on the general-purpose broach 100. The shape of the cutting elements 538A-538D corresponds to the shape of the base 254 on the inrate lay 250, allowing the inrate lay 250 to rest on the bone material reamed by the reaming head 524. Furthermore, as described in more detail in connection with FIGS. 11A and 11B, the spokes 104A-104E can be shaped to accommodate the presence of the reaming head 524. Specifically, the proximal surfaces of the blades 106A-106F can form bowl-shaped receptacles for the reaming head 524. In this manner, the proximal tips 124A, 124B, 124C, and 124E (see FIGS. 11A and 11B) of the universal broach 100 can be positioned above the lower portion of the reaming head 524 when the reaming head 524 is fully advanced.

[0048] 11A and 11B are top and side cross-sectional views of the general-purpose broach 100 of FIG. 1 , illustrating various features that facilitate cooperation with the reaming guide 500 to perform reaming for an inlay configuration. As discussed above, the general-purpose broach 100 may include a main body 102 and spokes 104A through 104F. The main body 102 may include a socket 105. The spoke 104A may include a blade 106A and a wing 108A. The spoke 104B may include a blade 106B and a wing 108B. The spoke 104C may include a blade 106C and a wing 108C. The spoke 104D may include a blade 106D. The spoke 104E may include a blade 106E and a wing 108E. The spoke 104F may include a blade 106F.

[0049] The main body 102 may include an upper surface 120. The blades 106A through 106F may include upper surfaces 122A through 122F. Additionally, the blades 106A, 106B, 106C, and 106E may include proximal tips 124A, 124B, 124C, and 124E, respectively. The upper surfaces 122A through 122F may extend laterally from the upper surface 120, e.g., parallel to the upper surface 120. The flat portions of the upper surfaces 122A through 122F may comprise approximately 75% of the diameter of the general-purpose broach 100. The radially outer portions of the upper surfaces 122A through 122F may curve proximally to form the proximal tips 124A, 124B, 124C, and 124E. Thus, the flat portions of upper surfaces 122A-122F can be recessed lower into the bone material than proximal tips 124A, 124B, 124C, and 124E, thus allowing reaming head 524 to advance deeper into the bone material. However, proximal tips 124A, 124B, 124C, and 124E can extend along the surface of the bone material within humerus 200 to provide support to and prevent damage to the bone material.

[0050] 12 is a diagram illustrating steps of the disclosed method related to preparing the humerus to receive a prosthetic implant. Method 600 can include steps 602 through 624, which describe various procedures for implanting a general-purpose broach and assessing shoulder joint laxity to determine whether an in-lay or on-lay trial component will or should be attached to the general-purpose broach. In various embodiments, additional steps can be included consistent with the devices, systems, methods, and processes described herein. Similarly, some of steps 602 through 624 can be omitted.

[0051] In step 602, the humerus 200 may be resected to form the resected surface 202. Resection of the humerus 200 may be performed using conventional techniques.

[0052] In step 604, the universal broach 100 can be attached to the inserter 300 of Figures 4A-5B. For example, the universal broach 100 can be inserted into the opening 324 so that the attachment portion 320 can be inserted into the socket 105 of the main body 102.

[0053] In step 606, the general-purpose broach 100 can be inserted into the resected surface 202. For example, the bottoms of the spokes 104A-104F can be pressed into the resected surface 202 by pushing the inserter 300 until the plate 308 engages the resected surface 202. The handle 304 of the inserter 300 can then be advanced relative to the base 302, further pressing the general-purpose broach 100 into the humerus 200, thereby recessing the top surfaces of the spokes 104A-104F below the resected surface 202. The top surfaces of the spokes 104A-104F can be positioned a distance D1 below the resected surface 202.

[0054] In step 608, the spacer 400 (see FIG. 6A) may be attached to the general-purpose broach 100. For example, the attachment portion 408 may be inserted into the socket 105 of the main body 102.

[0055] In step 610, the tension or laxity of the shoulder joint can be evaluated, assessed, or determined. For example, laxity of a joint such as shoulder joint 700 of FIG. 13 can be determined by assessing the tension in the soft tissue that holds the humerus in contact or approximation with the scapula. It is desirable to replicate the tension of a natural shoulder joint, where the soft tissue holds the bones in engagement but the joint is not overly tight and difficult for the patient to move. Thus, even if the spacer 400 cannot fit between the humerus and scapula, the soft tissue is holding the joint tight enough, allowing for the use of a shorter or deeper prosthetic implant, such as an inlay. However, if the spacer 400 can easily fit between the humerus and scapula, the soft tissue is not holding the joint tight enough, allowing for the use of a taller or shallower prosthetic implant, such as an inlay.

[0056] In step 612, the surgeon can determine that the spacer 400 can be easily fitted between the humerus and scapula. Thus, the surgeon can determine that the soft tissue does not hold the spacer thick enough to replicate the natural joint. Thus, the surgeon can determine that a taller or thicker (relative to the joint gap height) humeral head augmentation, e.g., a prosthetic implant, such as the on-late ray 206, can be used, if desired. For example, the joint tightness may be such that either an on-late ray or an on-late ray can function depending on the T1-T4 constructs.

[0057] In step 614, the surgeon can attach the on-rate ray 206 to the general-purpose broach 100. The spacer 400 can then be removed from the general-purpose broach 100, and the attachment portion 216 of the on-rate ray 206 can be inserted into the socket 105 of the main body 102. The surgeon can then complete a joint trial using the general-purpose broach 100 and the on-rate ray 206, for example, to build the final construct that will be implanted in the patient's body in step 624.

[0058] In step 616, the surgeon can determine that the spacer 400 cannot fit between the humerus and scapula, or cannot fit without excessive force. Thus, the surgeon can determine that the soft tissue is holding the joint tight enough that, if desired, a shorter or thinner humeral augmentation (relative to the joint gap height), e.g., prosthetic implant, such as the inlate-lay 250, can be used. For example, the joint tightness may be such that either an inlate-lay or an onlate-lay can work depending on the T1-T4 constructs.

[0059] In step 618, the surgeon can attach the reaming guide 500 to the general-purpose broach 100. Thus, the spacer 400 can be removed from the general-purpose broach 100, and the attachment portion 504 of the reaming guide 500 can be inserted into the socket 105 of the main body 102.

[0060] In step 620, the resected surface 202 can be reamed. The reamer 520 can be advanced over the reaming guide 500 to engage the reaming head 524 with the resected surface 202.

[0061] At step 622, the surgeon can attach the Inrate-Ray 250 to the general-purpose broach 100. The reaming guide 500 can then be removed from the general-purpose broach 100, and the attachment portion 258 of the Inrate-Ray 250 can be inserted into the socket 105 of the main body 102. The surgeon can then complete a joint trial using the general-purpose broach 100 and the Inrate-Ray 250, for example, to build the final construct that will be implanted in the patient's body at step 624.

[0062] After the surgical procedure is performed, the general-purpose broach 100 is removed from the patient, and the final prosthetic implant is left within the anatomy to function as a prosthetic joint. The final prosthetic implant has a shape similar to that of the general-purpose broach plus one of the on-lay 206 and prosthetic bearing component 230 or the in-lay 250 and prosthetic bearing component 270. The access incision within the patient can be closed using appropriate sutures or the like, leaving the prosthetic implant within the shoulder joint.

[0063] 13 is a schematic diagram of a shoulder joint 700 configured to receive a total shoulder replacement in a reverse shoulder configuration, in accordance with one embodiment of the present disclosure. Shoulder joint 700 may include a scapula 702 and a humerus 704. Shoulder joint 700 is one example of a joint in which the universal broach 100 of FIGS. 1-11B may be used.

[0064] A prosthetic glenoid 706 is implanted in the scapula 702. A prosthetic bearing 708 may be implanted in the humerus 704. The prosthetic glenoid 706 may be attached to an anchoring device 710. The prosthetic bearing 708 may include an articulation component 712, a tray 714, and an anchoring component 716. In the illustrated embodiment of FIG. 13, the anchoring component 716 includes a stem 718. The universal broach concepts of the present disclosure are applicable to broaches used with stemmed or stemless components. In some embodiments, the tray 714 may include an on-lay 206 or an in-lay 250, and the stem 718 may be omitted.

[0065] As discussed herein, the relaxation or tension between the scapula 702 and the humerus 704 can determine what type of prosthetic construct is used within the shoulder joint 700. Specifically, the relaxation or tension between the scapula 702 and the humerus 704 can determine whether an on-rate ray 206 or an in-rate ray 250 will be used after the prosthetic glenoid 706 is installed and the resected surface 720 is created. Thus, a gap G may exist between the resected surface 720 and the superior surface of the prosthetic glenoid 706 once implanted into the scapula 702. In the present application, if the spacer 400 fits within the gap G, e.g., if the gap G is thicker than the distance D4, the on-rate ray 206 can be used; if the spacer 400 does not fit within the gap G, e.g., if the gap G is thinner than the distance D4 minus D1, the in-rate ray 250 can be used. Additionally, if the spacer 400 fits within the gap G but the shoulder joint 700 is tight, for example, if there is excessive constraint between the prosthetic glenoid 706 and the spacer 400, the inlay 250 can be used.

[0066] Figures 14A and 14B are perspective views of a universal broach assembly 800 including a universal broach distal body 802 assembled with a universal broach proximal body 801. Figure 15 is a side view of the universal broach distal body 802 and universal broach proximal body 801 of Figures 14A and 14B. Figure 16 is a top view of the universal broach distal body 802 and universal broach proximal body 801 of Figures 14A and 14B. Figures 17A and 17B are perspective views of the universal broach proximal body 801 exploded from the universal broach distal body 802. Figures 14A through 17B will be discussed simultaneously.

[0067] The universal broach distal body 802 can include a broaching body, and the universal broach proximal body 801 can include a spacer body. The universal broach distal body 802 can be configured to perform broaching procedures for both inlay and onlay procedures. The universal broach distal body 802 can be used with the universal broach proximal body 801 for onlay and inlay procedures. The universal broach distal body 802 can be used to broach bone material with the universal broach proximal body 801 attached. For onlay procedures, the universal broach proximal body 801 can remain attached to the universal broach distal body 802 for trial use. For inlay procedures, the universal broach proximal body 801 can be detached from the universal broach distal body 802 for trial use.

[0068] The universal broach distal body 802 can be configured in a manner similar to the universal broach 100 of FIG. 1 described above to cut or displace bone material in a specific pattern to accommodate the anchor component of a prosthetic implant. The spokes 804A-804F can be spaced at either different or the same intervals to achieve a single overall spacing pattern. The universal broach proximal body 801 can be used with universal broach distal bodies 802 of different sizes. For example, the universal broach distal body 802 can have a first size for use with a first size implant. As discussed in connection with FIGS. 26A-27B, other sizes of universal broaches can be attached to the universal broach proximal body 801 for different sizes of bone. For example, other universal broaches can have broaching elements, such as the spokes 804A-804F of FIG. 19, that have a shorter overall diameter or length to allow the universal broach to be used with smaller implants. However, the size of the main body 803 can remain the same for different sized broaching elements such that the universal broach proximal body 801 can be used with universal broach distal bodies 802 of different sizes.

[0069] The universal broach distal body 802 and the universal broach proximal body 801 can be used with a modified version of the inserter 300 (see FIGS. 32 and 33 ) in which the attachment portion 320 is modified to accommodate the universal broach proximal body 801 for insertion at a fixed distance below the resected bone surface. In some embodiments, the universal broach proximal body 801 can have a thickness equal to the distance D1 (see FIGS. 2A and 2B ) to facilitate compatibility with the on-rate ray 206 (see FIG. 2B ) and the in-rate ray 250 (see FIG. 3B ) and assessment of bone material. The universal broach proximal body 801 and the universal broach distal body 802 can be used with a modified version of the spacer 400 (see FIG. 6A ) without the attachment portion 408 to assess joint laxity.

[0070] Figures 18 and 19 are top and bottom perspective views, respectively, of a universal broach distal body 802 of the present disclosure. Figures 20 and 21 are side and top views, respectively, of the universal broach distal body 802 of Figures 18 and 19. Figures 18 through 21 are discussed simultaneously.

[0071] Universal broach distal body 802 may include a main body 803 and spokes 804A through 804F. Spoke 804A may include a blade 806A and a wing 808A. Spoke 804B may include a blade 806B and a wing 808B. Spoke 804C may include a blade 806C and a wing 808C. Spoke 804D may include a blade 806D. Spoke 804E may include a blade 806E and a wing 808E. Spoke 804F may include a blade 806F. The main body may include a socket 810 and ports 812A and 812B.

[0072] Spokes 804A-804F can be configured to broach bone as described above in connection with spokes 104A-104F of universal broach 100 of FIG. 1 . Blades 806A-806F can project radially from main body 803 and extend distally of distal surface 814. Blades 806A-806F can extend proximal to proximal surface 816. However, the radially inner ends of blades 806A-806F on main body 803 can be reduced in height, for example, by including a chamfer to interface with proximal surface 816. Thus, the proximal or top side of universal broach distal body 802 can have an inwardly extending recess 817 to accommodate universal broach proximal body 801. Blades 806A-806F can thus form a bowl-shaped receptacle, as discussed herein. 1, blades 806A-806F may have radially extending surfaces 809A-809F that are at the same horizontal level as wings 808A, 808B, 808C, and 808E. As described in further detail below in connection with FIG. 33, radially extending surfaces 809A-809F of blades 806A-806F may be raised from main body 803 to facilitate the transmission of forces from shaft 318 of inserter 300 (see FIGS. 32 and 33) through universal broach proximal body 801 to universal broach distal body 802.

[0073] The proximal surface 816 may include ports 812A and 812B to facilitate coupling with the universal broach proximal body 801. The ports 812A and 812B may comprise cylindrical bores extending into the main body 803. In some embodiments, the ports 812A and 812B may comprise closed-ended bores extending into the proximal surface 816 and stopping short of the distal surface 814. The ports 812A and 812B may be positioned 180 degrees apart from one another within the main body 803. The ports 812A and 812B may allow for two-way coupling with the pegs 828A and 828B of the universal broach proximal body 801. That is, the pegs 828A and 828B of the universal broach proximal body 801 can couple to the ports 812A and 812B in two orientations. Proximal surface 816 may be flat to allow for flush mating with distal surface 832 (see FIG. 24) of universal broach proximal body 801. While FIGS. 18-20 show one version of ports 812A and 812B, other configurations are possible. For example, ports 812A and 812B may have other cross-sectional shapes, such as square, and may be positioned at other circumferential positions, such as 90 degrees from each other.

[0074] The socket 810 can have an upper portion and a lower portion. In some embodiments, the upper portion can include a rectangular slot having opposing arcuate walls connecting opposing straight walls. The opposing walls forming the upper portion can define an opening sized smaller than the tip 866 of the removal tool 860, as shown in FIG. 30 , to allow the shaft 862 of the removal tool 860 to be pressed against the distal body 802 of the universal broach. In some embodiments, the upper portion of the socket 810 can include a cylindrical bore. The upper portion of the socket 810 can be configured similarly to the socket 105 of the universal broach 100 of FIG. 1 . The socket 810 can be configured to mate with the mounting portion 504 of the reaming guide 500 (see FIGS. 10A and 10B ) and with the mounting portion 320 of the inserter 300 (see FIGS. 4A and 4B ). The upper portion of the socket 810 can be further configured to mate with the mounting portion 216 of the on-rate tray 206 (see FIG. 2B) and the mounting portion 258 of the in-rate tray 250 (see FIG. 3B). The upper portion can transition to the lower portion via a bowl shape. The lower portion can include a cylindrical bore with straight sidewalls. The lower cylindrical bore can allow passage of biological material and instruments through the universal broach distal body 802 and allow visualization of biological material distal to the universal broach distal body 802.

[0075] Figures 22 and 23 are top and bottom perspective views, respectively, of a universal broach proximal body 801 of the present disclosure. Figures 24 and 25 are side and top views, respectively, of the universal broach proximal body 801 of Figures 22 and 23. Figures 22 through 25 are discussed simultaneously.

[0076] The universal broach proximal body 801 may include a main body 820, a socket 822, spokes 824A to 824F, a notch 826, and pegs 828A and 828B. The main body 820 may include an annular ring for mating with the main body 803 of the universal broach distal body 802 of FIGS. 18 to 21. The proximal surface 830 of the main body 820 may be flat and include a notch 826. The distal surface 832 may be flat to facilitate mating with the proximal surface 816 of the main body 803 (see FIG. 18). The distal surface 832 may extend further distally than the spokes 824A to 824F to form an extension 833 for mating with the recess 817 of the universal broach distal body 802 (see FIG. 21). Pegs 828A and 828B can extend from distal surface 832 and can be disposed to align with ports 812A and 812B, respectively. Pegs 828A and 828B can include semicircular extensions having lengths equal to or less than ports 812A and 812B. The outer diameters of pegs 828A and 828B can have outer dimensions such that pegs 828A and 828B fit snugly inside ports 812A and 812B to prevent movement or jamming therebetween.

[0077] Spokes 824A-824F can have different lengths. The lengths of spokes 824A-824F can vary based on the lengths of spokes 804A-804F of universal broach distal body 802. In some embodiments, spokes 824B, 824C, and spoke 824E can be longer than spokes 824A, 824D, and 824F. Ports 812A and 812B can be arranged in two different ways to accommodate pegs 828A and 828B such that spokes 824A, 824C, and 824E are positioned to rest on top of spokes 804A-804F that have equal or longer lengths. In various embodiments, universal broach proximal body 801 can be configured to attach to any size universal broach distal body 802 such that none of spokes 824A-824F extend beyond any of spokes 804A-804F. In some embodiments, spokes 824A to 824F can be configured to have the same length as spokes 804A to 804F for the smallest size universal broach distal body 802, such as universal broach distal body 802B of FIG. 27A.

[0078] The proximal surface 830 can be flat and configured to engage the shaft 318 of the inserter 300, as shown in FIG. 33 . A bevel 834 can be positioned between the proximal surface 830 and the socket 822. The bevel 834 can be configured to provide a surface to guide the engagement of the tip 866 of the removal tool 860 into the socket 822, as shown in FIG. 30 . The socket 822 can be sized to allow the shaft 862 of the removal tool 860 to pass therethrough. However, the socket 822 can include a flange 836 for engaging the shaft 862. In some embodiments, the shaft 862 and the flange 836 can have complementary threads to enable a threaded engagement therebetween. Thus, the shaft 862 can be threaded through the universal broach proximal body 801, as shown in FIGS. 30 and 31 . The socket 822 and flange 836 can further be sized to allow the extension portion 833 (see FIG. 32) of the inserter 300 to pass therethrough. The socket 822 can be configured to engage the attachment portion 216 (see FIG. 2B) of the on-rate ray 206, in which case the stem 210 is shortened to accommodate the universal broach proximal body 801 being closer to the resected bone surface.

[0079] Figure 26A is a side view of a first size general-purpose broach proximal body 801 and a general-purpose broach distal body 802A. Figure 26B is a top view of the general-purpose broach distal body 802A and the general-purpose broach proximal body 801 of Figure 26A inserted into the resected surface 850A of the humerus 852A. The general-purpose broach distal body 802A can include a main body 803A and spokes similar to the spokes 804A-804F of the general-purpose broach distal body 802.

[0080] In the illustrated embodiment, the universal broach distal body 802A can be the same size as the universal broach distal body 802 of FIGS. 18-21. The universal broach proximal body 801 can be configured to rest on top of the universal broach distal body 802A with the pegs 828A and 828B aligned within ports, such as ports 812A and 812B, within the universal broach distal body 802A. As can be seen in FIG. 26A, the universal broach distal body 802A can have a larger outer diameter than the universal broach proximal body 801. As can be seen in FIG. 26B, the spokes 804A-804F of the universal broach distal body 802A can extend beyond the spokes 824A-824F of the universal broach proximal body 801.

[0081] Figure 27A is a side view of a second size general-purpose broach proximal body 801 and a general-purpose broach distal body 802B. Figure 27B is a top view of the general-purpose broach distal body 802B and the general-purpose broach proximal body 801 of Figure 27A inserted into the resected surface 850B of the humerus 852B. The general-purpose broach distal body 802B may include a main body 803B and spokes similar to the spokes 804A-804F of the general-purpose broach distal body 802, but with shorter lengths and heights.

[0082] In the illustrated embodiment, the universal broach distal body 802B can be smaller than the universal broach distal body 802 of FIGS. 18-21. The universal broach proximal body 801 can be configured to rest on top of the universal broach distal body 802B with the pegs 828A and 828B aligned within ports, such as ports 812A and 812B, within the universal broach distal body 802B. As can be seen in FIG. 27A , the universal broach distal body 802B can have the same outer diameter as the universal broach proximal body 801. As can be seen in FIG. 27B , the spokes 804A to 804F of the universal broach distal body 802B can extend the same distance as the spokes 824A to 824F of the universal broach proximal body 801.

[0083] Universal broach distal bodies 802A and 802B can be configured in a similar fashion to universal broach distal body 802 for mating with universal broach proximal body 801 and cutting bone, but can have different cutting pattern scales. The spacing between the spokes of universal broach distal bodies 802A and 802B can be the same to facilitate compatibility with the spokes of universal broach proximal body 801 and form the same spacing pattern. Multiple discontinuously sized universal broach assemblies 800 can be provided, with sizes between universal broach distal body 802A and universal broach distal body 802B. Main bodies 803A and 803B can be configured in a similar fashion to main body 803 to maintain compatibility with universal broach proximal body 801. However, spokes 804A-824F can be scaled up or down, e.g., longer or shorter, and / or longer or shorter, to create different broaching patterns in the bone for different sized implants and different sized bones. It is possible to provide a set of universal broach distal bodies 802 that accommodate different sized humeral implants.

[0084] The placement of spokes 824A-824F on the superior surface of spokes 804A-804F provides the surgeon with a way to visualize the relationship of spokes 804A-804F to the outer cortical bone wall of humerus 852A and 852B, as well as the proximity of spokes 824A-824F to resected surfaces 850A and 850B. Thus, the surgeon can assess the positioning and depth of universal broach distal bodies 802A-802B in the bone, the latter of which can aid in assessing whether an onlay or inlay implant is needed or desired.

[0085] FIG. 28 is a perspective view of a removal tool 860 suitable for use with the universal broach proximal body 801 and the universal broach distal body 802 of FIGS. 14A-27B. The removal tool 860 may include a shaft 862, a head 864, a tip 866, and a bore 868. The head 864 may include a knob with grooves to facilitate gripping and rotating the shaft 862. The shaft 862 may provide a sufficient length to allow the tip 866 to be inserted into the anatomy and engage the universal broach distal body 802 through the universal broach proximal body 801. The tip 866 may include threads for engaging the flange 836 (see FIG. 25), as discussed herein. The bores 868 and 870 (see FIG. 29) may allow for the passage of fluids or other objects, such as pins, through the removal tool 860. For example, a pin may be located within the bore 868 to facilitate rotation of the shaft 862. Additionally, bore 870 may include a threaded, closed-ended bore to allow for coupling to a slap hammer device, if desired or required, to facilitate removal of universal broach proximal body 801 from universal broach distal body 802. In embodiments, removal tool 860 may be made of stainless steel.

[0086] 29 is a perspective view of removal tool 860 attached to universal broach distal body 802 assembled with universal broach proximal body 801. Tip 866 of the removal tool is insertable into socket 822 of universal broach proximal body 801 for engagement with universal broach distal body 802. Head 864 can be rotated to rotate shaft 862 and engage threads on flange 836 with threads on tip 866 (see FIG. 25).

[0087] FIG. 30 is a side view of removal tool 860 advanced to separate universal broach proximal body 801 from universal broach distal body 802. Continued rotation of head 864 can rotate shaft 862, further advancing the threads on tip 866 through the threads on flange 836 (see FIG. 25 ). As tip 866 advances through universal broach proximal body 801, the distal end of tip 866 can engage and press against proximal surface 816 of universal broach distal body 802. The engagement of pegs 828A and 828B with ports 812A and 812B can prevent rotation of universal broach proximal body 801. Thus, universal broach proximal body 801 can be induced to rise along the threads on tip 866 as tip 866 rotates against universal broach distal body 802.

[0088] FIG. 31 is a perspective view of the universal broach proximal body 801 and removal tool 860 separated from the universal broach distal body 802. Continued rotation of the head 864 can rotate the shaft 862, further advancing the threads on the tip 866 through the threads on the flange 836 (see FIG. 25 ). The universal broach proximal body 801 can continue to rise along the threads on the tip 866, completely disengaging the pegs 828A and 828B from the ports 812A and 812B. The removal tool 860 can then be pulled away from the anatomy, carrying the universal broach proximal body 801 with it. Thus, the removal tool 860 can facilitate separation of the universal broach proximal body 801 from the universal broach, for example, by overcoming friction between the pegs 828A and 828B and the ports 812A and 812B, and between the spokes 824A through 824F and the bone material.

[0089] Figure 32 is a cross-sectional view of the general-purpose broach proximal body 801 and the general-purpose broach distal body 802 of Figures 14A-27B attached to an inserter 300. Figure 33 is a side view of the inserter 300 of Figure 21 actuated to drive the general-purpose broach proximal body 801 and the general-purpose broach distal body 802 into bone.

[0090] The inserter 300 of FIGS. 32 and 33 can be configured similarly to the inserter 300 of FIGS. 4A-5B , except that the extension portion 833 is longer than the extension portion 321. The extension portion 833 can position the attachment portion 320 a distance DD below the shaft 318 to allow the attachment portion 320 to extend through the proximal spacer body 301 and engage the universal broach distal body 802. The shaft 318 can be shortened to accommodate the increased length of the extension portion 833. In some embodiments, the distance DD can be equal to the height of the proximal spacer body 301, which can be equal to the distance D1 in FIGS. 2A and 2B . The bottom or distal surface of the shaft 318 rests on top of the spokes 824A-824F of the universal broach proximal body 801, thereby facilitating the transfer of force from the shaft 318 to the universal broach distal body 802. This may facilitate easier insertion of the general-purpose broach distal body 802 compared to the general-purpose broach 100 of FIGS. 4A-5B, in which most or all of the force from the shaft 318 is transmitted through the attachment portion 320.

[0091] 34 is a diagram illustrating a method 900 including steps 902 through 928 of the present disclosure related to implanting an inlay or on-rate ray using a universal broach distal body 802 and a universal broach proximal body 801 of the present disclosure. Method 900 may include steps 902 through 928 describing various procedures for implanting a universal broach and assessing shoulder joint laxity to determine whether an in-rate ray or on-rate ray trial component will or should be attached to the universal broach. In various embodiments, additional steps may be included consistent with the devices, systems, methods, and steps described herein. Likewise, some of steps 902 through 928 may be omitted.

[0092] In step 902, the humerus 200 (see FIG. 2A) can be resected to form resected surface 202. Resection of the humerus 200 can be performed using conventional techniques. Resected surface 202 can include resected surface 850A of FIG. 26B and resected surface 850B of FIG. 27B.

[0093] In step 904, a version of the spacer 400 (see FIG. 6A ) that does not include the attachment portion 408 can be inserted between the resected surface 850A or 850B of the humerus 852A or 852B and the scapula. The bottom surface of the head 402 is slidable across the resected surface 202 without interference. Thus, the surgeon can manipulate the spacer 400 by sliding the head 402 back and forth to ensure the prosthetic head implant engages the articular surface 406 and assess the joint.

[0094] In step 906, the tension or laxity of the shoulder joint can be evaluated, assessed, or determined. For example, laxity of a joint, such as shoulder joint 700 of FIG. 13, can be determined by assessing the tension in the soft tissue that holds the humerus at the point of contact or approximation with the scapula. It is desirable to replicate the tension of a natural shoulder joint, where the soft tissue holds the bones in engagement but the joint is not overly tight and difficult for the patient to move. Thus, if the spacer 400 cannot fit between the humerus and scapula, the soft tissue will hold the joint tight enough that a shorter (as opposed to extending beyond the resected surface 202) or deeper (as opposed to inserting within the resected surface 202) prosthetic implant, such as an inlay, can be used. However, if the spacer 400 fits easily between the humerus and scapula, this may be an indication that the soft tissue is not holding the joint tightly enough, and therefore a taller (as opposed to extending beyond the resected surface 202) or shallower (as opposed to inserting into the resected surface 202) prosthetic implant, such as an on-lay, may be used.

[0095] In step 908, the universal broach proximal body 801 can be assembled with the universal broach distal body 802. As discussed, pegs 828A and 828B can be inserted into ports 812A and 812B.

[0096] In step 910, inserter 300 (see FIGS. 32 and 33 ) can be used to insert universal broach distal body 802 and universal broach proximal body 801 into resected surface 850A or 850B. Mounting portion 320 can be passed through universal broach proximal body 801 and attached to socket 810 of universal broach distal body 802. The bottom surface of shaft 318 can be pressed against universal broach proximal body 801 to drive universal broach distal body 802 into bone. Inserter 300 can be released from universal broach distal body 802, leaving universal broach distal body 802 and proximal spacer body 301 positioned on the bone.

[0097] At step 912, the surgeon can decide to use an in-lay or on-lay using the information obtained at step 904. If desired, the surgeon can re-evaluate the joint using spacer 400 to confirm that the previous evaluation at step 904 was acceptable.

[0098] In step 914, the surgeon can determine that the spacer 400 can be easily fitted between the humerus and scapula. Thus, the surgeon can determine that the soft tissue does not hold the spacer thick enough to replicate the natural joint. Thus, the surgeon can determine that a taller or thicker (relative to the joint gap height) humeral head augmentation, e.g., a prosthetic implant, such as the on-late ray 206, can be used, if desired. For example, the joint tightness may be such that either an on-late ray or an on-late ray can function depending on the T1-T4 constructs.

[0099] In step 916, the surgeon can attach the on-rate ray 206 (see FIG. 2B ) to the universal broach proximal body 801, which is coupled to the universal broach distal body 802. Thus, the attachment portion 216 of the on-rate ray 206 can be inserted into the socket 822 of the main body 820.

[0100] In step 918, the surgeon may complete a joint trial using the universal broach distal body 802, the universal broach proximal body 801, and the on-rate tray 206 to build the final construct that will be implanted in the patient. For example, different sizes of prosthetic bearing components 230 may be attached to the on-rate tray 206 to determine the construct and final joint laxity for the final prosthetic or untried implant to be used.

[0101] In step 920, the surgeon can determine that the spacer 400 cannot immediately fit between the humerus and scapula. Thus, the surgeon can determine that the spacer 400 cannot fit between the humerus and scapula, or cannot fit without excessive force. Thus, the surgeon can determine that the soft tissue is holding the joint tight enough that a shorter or thinner humeral augmentation (relative to the joint gap height), e.g., prosthetic implant, such as the inlate-lay 250 (see FIG. 3B), can be used, if desired. For example, the joint tightness may be such that either an inlate-lay or an onlate-lay can work depending on the constructs at T1 through T4.

[0102] In step 922, the universal broach proximal body 801 may be separated from the universal broach distal body 802. In some embodiments, the universal broach proximal body 801 may be manually removed. In some embodiments, a removal tool 860 (see FIGS. 28-31 ) may be used.

[0103] In step 924, the surgeon may attach the reaming guide 500 (see FIG. 7) to the universal broach distal body 802. The attachment portion 504 of the reaming guide 500 may be inserted into the socket 810 of the main body 803.

[0104] The resected surface 850A or 850B can be reamed in step 926. The reamer 520 (see FIG. 9) can be advanced over the reaming guide 500 to engage the reaming head 524 with the resected surface 850A or 850B.

[0105] At step 928, the surgeon can attach the Inrate-Ray 250 to the universal broach distal body 802. The reaming guide 500 can then be removed from the universal broach distal body 802, and the attachment portion 258 of the Inrate-Ray 250 can be inserted into the socket 810 of the main body 803. The surgeon can then complete a joint trial using the universal broach distal body 802 and the Inrate-Ray 250, for example, to build the final construct that will be implanted in the patient's body at step 918.

[0106] The systems, devices and methods discussed in this application can provide the following useful advantages.

[0107] 1) The subject matter can facilitate assessment of laxity or tension in a joint, such as a shoulder joint, for different types of implants before one or more bones of the joint are modified such that the modified bone becomes incompatible with at least one of the different types of implants, thereby avoiding premature and irreversible modification of the bone.

[0108] 2) The subject matter can reduce the amount of instrumentation involved in performing an arthroplasty procedure by eliminating the need for multiple broaches for in-lay and on-lay constructions, as well as eliminating the need for trial anchors for such constructions.

[0109] 3) The subject matter can reduce the time to perform an arthroplasty procedure by simplifying the arthroplasty process and the joint tension assessment process, e.g., a single incision can be used for both in-lay and on-lay, and a single spacer device can be used to assess joint tension for the in-lay and on-lay.

[0110] (Example) Example 1 is a broach for preparing bone to receive an anchor for a prosthetic implant, the broach including a body having an upper surface and a socket extending into the upper surface, and a first anchoring component extending from the body including spokes extending laterally from the body and spoke tips extending proximally from the spokes above the upper surface.

[0111] In Example 2, the subject matter of Example 1 optionally includes: the first anchoring component includes a blade extending laterally from the body and a wing extending circumferentially from the blade.

[0112] In Example 3, the subject matter of Example 2 optionally includes: the blade including a proximal surface extending arcuately upward from the upper surface and a distal edge configured to cut bone material.

[0113] In Example 4, the subject matter of any one or more of Examples 1 to 3 optionally includes that the first anchoring component comprises one of a plurality of anchoring components extending laterally from the body.

[0114] In Example 5, the subject matter of Example 4 optionally includes, wherein the plurality of anchoring components form a bowl-shaped receptacle for receiving a reamer.

[0115] Example 6 is a system for preparing bone to accommodate a prosthetic implant, comprising: a broach including a body including a socket extending into an upper surface of the body and an anchoring component extending from the body; a spacer including an attachment component configured to attach to the socket and a spacer body attached to the attachment component; an onlay implant including a second attachment component configured to attach to the socket, a planar base attached to the second attachment component, and a first bearing component attached to the planar base; and an inlay implant including a third attachment mechanism configured to attach to the socket, a bowl-shaped base attached to the third attachment mechanism, and a second bearing component attached to the bowl-shaped base, wherein the spacer body has a thickness equal to the maximum gap thickness of the inlay implant.

[0116] In Example 7, the subject matter of Example 6 optionally includes, wherein the maximum gap thickness comprises a constant distance between a bottom of the articular surface of the second bearing component and a bottom of the bowl-shaped base.

[0117] In Example 8, the subject matter of any one or more of Examples 6 to 7 optionally includes that the bowl-shaped base is connectable to a plurality of different second bearing components, each having a different thickness.

[0118] In Example 9, the subject matter of Example 8 optionally includes a plurality of different second bearing components also attachable to the planar base of the onlay implant.

[0119] In Example 10, the subject matter of any one or more of Examples 6 to 9 optionally includes the onlay implant and broach together forming an onlay trial device, and the inlay implant and broach together forming an inlay trial device.

[0120] In Example 11, the subject matter of any one or more of Examples 6-10 optionally includes an insertion device configured to insert the broach a distance into the bone.

[0121] In Example 12, the subject matter of any one or more of Examples 6 to 11 optionally includes a reamer guide configured to attach to a socket of the broach and a reamer configured to slide along the reamer guide, the reamer including a reamer head configured to advance along the reamer guide to fit into a bowl-shaped receptacle formed by the upper surface of the broach.

[0122] Example 13 is a method of implanting a prosthetic component into bone, comprising inserting a broach into a resected surface of a first bone of a joint, attaching a spacer to the broach, positioning the spacer in a space between the first bone of the joint and a second bone of the joint while attached to the broach, determining the use of an inlate or onlate ray based on the laxity of the joint with the spacer inserted therein, attaching the onlate ray to the broach if the joint is loose, and attaching the inlate ray to the broach if the joint is tight.

[0123] In Example 14, the subject matter of Example 13 optionally includes attaching the inlay to the broach when the joint is locked includes reaming the resected surface of the bone.

[0124] In Example 15, the subject matter of Example 14 optionally includes the step of reaming the resected surface of the bone comprising attaching a reamer guide to the broach and advancing a reamer on the reamer guide to ream the resected surface, the reamer advancing into a bowl-shaped receptacle formed by the upper surface of the broach.

[0125] In Example 16, the subject matter of any one or more of Examples 13 to 15 optionally includes inserting the broach into the resected surface of the first bone of the joint includes inserting the broach a certain distance below the resected surface for both inlay and onlay.

[0126] In Example 17, the subject matter of Example 16 optionally includes the step of inserting the broach assembly into the resected surface of the first bone of the joint comprising loading the broach assembly into the inserter so that the blade of the broach extends from the inserter, forcing the blade of the broach into the bone material of the first bone until the inserter contacts the first bone, and actuating the inserter to drive the distal broach body further a distance into the first bone.

[0127] In Example 18, the subject matter of any one or more of Examples 13 to 17 optionally includes the step of attaching the on-late ray to the broach when the joint is loose, including positioning a bottom surface of the on-late ray against the resected surface.

[0128] In Example 19, the subject matter of Example 18 optionally includes the step of: when the spacer fits within the space between the first bone and the second bone, the joint is loose.

[0129] In Example 20, the subject matter of any one or more of Examples 13 to 19 optionally includes, when the joint is locked, attaching the inlate ray to the broach by positioning the bottom surface of the inlate ray within the resected surface.

[0130] In Example 21, the subject matter of Example 20 optionally includes the joint being locked when the spacer does not fit within the space between the first bone and the second bone.

[0131] In Example 22, the subject matter of any one or more of Examples 13 to 21 optionally includes adding one of multiple bearing components, each having a different thickness, to the inlay to adjust joint laxity.

[0132] In Example 23, the subject matter of any one or more of Examples 13 to 22 optionally includes adding one of multiple bearing components, each having a different thickness, to the on-lay to adjust joint laxity.

[0133] In Example 24, the subject matter of any one or more of Examples 13 to 23 optionally includes the step of inserting a broach into the resected surface of the first bone of the joint including inserting a pin into the resected surface and reaming an initial bore into the resected surface to accommodate the main body of the broach.

[0134] Example 25 is a system for preparing bone to accommodate a prosthetic implant anchor, comprising: a first distal broach component including a first broach body, a first socket extending into a first upper surface of the first broach body, and a first plurality of cutting spokes extending radially from the first broach body, each of the first plurality of cutting spokes separated by a spacing pattern; and a proximal broach component including a spacer body configured to attach to the first upper surface of the first broach body, and a plurality of spacer spokes extending radially from the spacer body, each of the spacer spokes separated by a spacing pattern.

[0135] In Example 26, the subject matter of Example 25 optionally further includes a second distal broach component, the second distal broach component including a second broach body, a second socket extending into a second upper surface of the second broach body, and a second plurality of cutting spokes extending radially from the second broach body, each of the second plurality of cutting spokes separated by a spacing pattern, at least some of the second plurality of cutting spokes being longer than any of the first plurality of cutting spokes.

[0136] In Example 27, the subject matter of any one or more of Examples 25 to 26 optionally includes that the first broach body includes a first coupler and the spacer body includes a second coupler configured to mate with the first coupler.

[0137] In Example 28, the subject matter of any one or more of Examples 25 to 27 optionally includes that the first plurality of cutting spokes each include a spoke extending laterally from the first broach body and a blade edge extending along the spoke.

[0138] In Example 29, the subject matter of Example 28 optionally includes, wherein each of the first plurality of cutting spokes includes a spoke tip extending proximally from the cutting spoke above the upper surface of the first broach body, and a radially extending surface extending flush with the spoke tip toward the first socket.

[0139] In Example 30, the subject matter of any one or more of Examples 25 to 29 optionally includes an onlay implant including a second attachment component configured to be attached to the spacer body, a planar base attached to the second attachment component, and a first bearing component attached to the planar base, and an inlay implant including a third attachment mechanism configured to be attached to the first socket, a bowl-shaped base attached to the third attachment mechanism, and the second bearing component attached to the bowl-shaped base, wherein the spacer body has a thickness equal to the maximum gap thickness of the inlay implant.

[0140] In Example 31, the subject matter of Example 30 optionally includes a spacer paddle including a spacer body and a handle extending from the spacer body, wherein the spacer body has a thickness equal to the maximum gap thickness of the inlay implant.

[0141] In Example 32, the subject matter of any one or more of Examples 30 to 31 optionally includes that the maximum gap thickness constitutes the distance between the bottom of the articular surface of the second bearing component and the bottom of the bowl-shaped base.

[0142] In Example 33, the subject matter of any one or more of Examples 30 to 32 optionally includes that the bowl-shaped base is connectable to a plurality of different second bearing components, each having a different thickness.

[0143] In Example 34, the subject matter of Example 33 optionally includes a plurality of different second bearing components also attachable to the planar base of the onlay implant.

[0144] In Example 35, the subject matter of any one or more of Examples 30 to 34 optionally includes the onlay implant, the proximal broach component, and the first distal broach component together forming an onlay trial device, and the inlay implant and the first distal broach component together forming an inlay trial device.

[0145] In Example 36, the subject matter of any one or more of Examples 30 to 35 optionally includes an insertion device configured to insert the first distal broach component and the proximal broach component a certain distance into the bone.

[0146] In Example 37, the subject matter of any one or more of Examples 30 to 36 optionally includes a reamer guide configured to be attached to a first socket of the first distal broach component, and a reamer configured to slide along the reamer guide, the reamer including a reamer head configured to advance along the reamer guide to fit within a bowl-shaped receptacle formed by the upper surface of the first distal broach component.

[0147] In Example 38, the subject matter of any one or more of Examples 30 to 37 optionally includes a removal tool including a knob, a shaft extending from the knob, and a threaded tip configured to threadably engage with the spacer body of the proximal broach component.

[0148] Example 39 is a method for implanting a prosthetic component into a bone, comprising: resecting a surface of a first bone of a joint; inserting a spacer paddle to assess loosening of the first bone of the joint; assembling a proximal spacer body and a distal broach body to form a broach assembly; inserting the broach assembly into the resected surface of the first bone of the joint; determining to use an inlate ray or an onlate ray based on the assessed loosening of the first bone of the joint; if the joint is loose, attaching the onlate ray to the broach assembly; and if the joint is tight, attaching the inlate ray to the distal broach body.

[0149] In Example 40, the subject matter of Example 39 optionally includes the step of attaching the inlay to the distal broach body when the joint is closed including removing the proximal spacer body from the distal broach body when the joint is closed and reaming the resected surface of the bone.

[0150] In Example 41, the subject matter of Example 40 optionally includes the step of reaming the resected surface of the bone comprising attaching a reamer guide to the distal broach body and advancing a reamer over the reamer guide to ream the resected surface, the reamer advancing into a bowl-shaped receptacle formed by the upper surface of the distal broach body.

[0151] In Example 42, the subject matter of any one or more of Examples 39 to 41 optionally includes the step of inserting the broach assembly into the resected surface of the first bone of the joint including inserting the distal broach body a fixed distance below the resected surface for both the inlay and the onlay, the fixed distance being equal to the height of the proximal spacer body.

[0152] In Example 43, the subject matter of Example 42 optionally includes the step of inserting the broach assembly into the resected surface of the first bone of the joint including loading the broach assembly into the inserter so that the blade of the distal broach body extends from the inserter, forcing the blade of the distal broach body into the bone substance of the first bone until the inserter contacts the first bone, and actuating the inserter to drive the distal broach body further a distance into the first bone, thereby positioning the proximal spacer body within the bone.

[0153] In Example 44, the subject matter of any one or more of Examples 39 to 43 optionally includes the step of attaching the on-rate ray to the broach assembly when the joint is loose, including positioning a bottom surface of the on-rate ray against the resected surface.

[0154] In Example 45, the subject matter of Example 44 optionally includes the joint being loose when the spacer paddle fits within the space between the second bone and the first bone forming the first bone of the joint.

[0155] In Example 46, the subject matter of any one or more of Examples 39 to 45 optionally includes the step of attaching the inlay to the distal broach body when the joint is locked including positioning the bottom surface of the inlay within the resected surface.

[0156] In Example 47, the subject matter of Example 46 optionally includes the fact that the joint is locked when the spacer paddle does not fit within the space between the first bone and the second bone forming the first bone of the joint.

[0157] In Example 48, the subject matter of any one or more of Examples 39 to 47 optionally includes adding one of multiple bearing components, each having a different thickness, to the inlay to adjust joint laxity.

[0158] In Example 49, the subject matter of any one or more of Examples 39 to 48 optionally includes adding one of multiple bearing components, each having a different thickness, to the on-lay to adjust joint laxity.

[0159] In Example 50, the subject matter of any one or more of Examples 39 to 49 optionally includes the step of inserting the broach assembly into the resected surface of the first bone of the joint including inserting a pin into the resected surface and reaming an initial bore into the resected surface to accommodate the main body of the distal broach body.

[0160] These non-limiting examples may each stand alone or may be combined in various permutations or combinations with one or more of the other examples.

[0161] Various notes The foregoing detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the inventors also contemplate examples using any combinations and permutations of the shown or described elements (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof) or with respect to any other example (or one or more aspects thereof) shown or described herein.

[0162] In the event of a conflict in usage between this specification and any document so incorporated by reference, the usage in this specification will control.

[0163] The words "a" or "an" are used herein, as is common in patent documents, to include one or more, independently of any other instance or usage, such as "at least one" or "one or more." The word "or" is used herein to mean a non-exclusive or, unless otherwise indicated, such that "A or B" includes "A but not B," "B but not A," and "A and B." The terms "including" and "in" are used herein to refer to one or more than one. The term "which" is used as the plain English equivalent of the terms "comprising" and "wherein," respectively. Similarly, in the following claims, "including" and "comprising" are open-ended; that is, systems, devices, products, compositions, formulations, or processes that include elements in addition to the elements recited after such a term in a claim are still deemed to be within the scope of that claim. Moreover, in the following claims, terms such as "first," "second," and "third" are used merely as labels and are not intended to impose numerical requirements on their objects.

[0164] The foregoing description is illustrative, not limiting. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. For example, other embodiments may be possible for one of ordinary skill in the art upon reviewing the foregoing description. The Abstract is provided to comply with 37 C.F.R. 1.72(b) to enable the reader to quickly ascertain the contents of the technical disclosure. The Abstract is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Similarly, in the foregoing Detailed Description, various features may be grouped together for the purpose of streamlining the disclosure. This should not be construed as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may reside in fewer than all features of a particular disclosed embodiment. Accordingly, the following claims are herein incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full range of equivalents to which such claims are entitled.

Claims

1. 1. A system for preparing bone to receive a prosthetic implant anchor, comprising: a first distal broach component, a first broach body; a first socket extending into a first top surface of the first broach body; a first plurality of cutting spokes extending radially from the first broach body, each cutting spoke being separated by a spacing pattern; the first distal broach component comprising: A proximal broach component comprising: a spacer body configured to attach to the first upper surface of the first broach body; a plurality of spacer spokes extending radially from the spacer body, each spacer spoke being separated by the spacing pattern; the proximal broach component comprising: A system comprising:

2. and a second distal broach component, the second distal broach component comprising: a second broach body; a second socket extending into a second upper surface of the second broach body; a second plurality of cutting spokes extending radially from the second broach body, each of the second plurality of cutting spokes being separated by the spacing pattern; The system of claim 1 , wherein at least some of the second plurality of cut spokes are longer than the first plurality of cut spokes.

3. the first broach body includes a first coupler; The system of claim 1 , wherein the spacer body includes a second coupler configured to mate with the first coupler.

4. Each of the first plurality of cut spokes comprises: a spoke extending laterally from the first broach body; a blade edge extending along the spoke; Including, 2. The system of claim 1, wherein each of the first plurality of cutting spokes includes a spoke tip extending proximally from the cutting spoke above the top surface of the first broach body and a radially extending surface extending flush with the spoke tip toward the first socket.

5. An onlay implant, a second mounting component configured to mount to the spacer body; a planar base attached to the second mounting component; a first bearing component attached to the planar base; the onlay implant comprising: An inlay implant, a third attachment mechanism configured to attach to the first socket; a bowl-shaped base attached to the third attachment mechanism; a second bearing component attached to the bowl-shaped base; and the inlay implant comprising: further comprising The system of claim 1 , wherein the spacer body has a thickness equal to a maximum gap thickness of the inlay implant.

6. a spacer paddle including the spacer body and a handle extending from the spacer body; the spacer body having a thickness equal to a maximum gap thickness of the inlay implant; The system of claim 5 , wherein the maximum gap thickness comprises the distance between a bottom of the articular surface of the second bearing component and a bottom of the bowl-shaped base.

7. 6. The system of claim 5, wherein the bowl-shaped base is connectable to a plurality of different second bearing components having different thicknesses, and the plurality of different second bearing components are also attachable to the planar base of the onlay implant.

8. the onlay implant, the proximal broach component, and the first distal broach component together form an onlay trial device; The system of claim 5 , wherein the inlay implant and the first distal broach component together form an inlay trial device.

9. an insertion device configured to insert the first distal broach component and the proximal broach component a distance into bone; A removal tool, comprising: Knob and a shaft extending from the knob; a threaded tip configured to threadably engage the spacer body of the proximal broach component; the removal tool, The system of claim 5 further comprising:

10. a reamer guide configured to attach to the first socket of the first distal broach component; a reamer configured to slide along the reamer guide, the reamer including a reamer head configured to advance along the reamer guide to fit within a bowl-shaped receptacle formed by an upper surface of the first distal broach component; and The system of claim 5 further comprising:

11. 1. A method of implanting a prosthetic component into bone, comprising: resecting a surface of a first bone of the joint; inserting a spacer paddle to assess laxity of the first bone of the joint; assembling the proximal spacer body and the distal broach body to form a broach assembly; inserting the broach assembly into a resected surface of the first bone of the joint; determining whether to use an in-lay or an on-lay based on the assessed laxity of the first bone of the joint; attaching the on-rate ray to the broach assembly when the joint is loose; attaching the inlate lay to the distal broach body when the joint is locked; A method comprising:

12. Attaching the inlate lay to the distal broach body when the joint is locked comprises: removing the proximal spacer body from the distal broach body when the joint is locked; reaming the resected surface of the bone; The method of claim 11 , comprising:

13. Reaming the resected surface of the bone comprises: attaching a reamer guide to the distal broach body; advancing a reamer over the reamer guide to ream the resected surface. The method of claim 12 , wherein the reamer is advanced into a bowl-shaped receptacle formed by an upper surface of the distal broach body.

14. 12. The method of claim 11, wherein inserting the broach assembly into the resected surface of the first bone of the joint includes inserting the distal broach body a distance below the resected surface for both the in-lay and the on-lay, the distance being equal to the height of the proximal spacer body.

15. Inserting the broach assembly into the resected surface of the first bone of the joint comprises: loading the broach assembly into the inserter such that the blades of the distal broach body extend from the inserter; forcing the blade of the distal broach body into the bone material of the first bone until the inserter contacts the first bone; activating the inserter to further drive the distal broach body into the first bone the distance, thereby positioning the proximal spacer body inside the bone; 15. The method of claim 14, comprising:

16. 12. The method of claim 11, wherein attaching the on-rate tray to the broach assembly when the joint is loose includes positioning a bottom surface of the on-rate tray against the resected surface, and wherein the joint is loose when the spacer paddle fits within a space between the first bone and a second bone that forms the first bone of the joint.

17. 12. The method of claim 11, wherein attaching the inlate lay to the distal broach body when the joint is locked comprises positioning a bottom surface of the inlate lay inside the resected surface, and wherein the joint is locked when the spacer paddle does not fit within a space between the first bone and a second bone that forms the first bone of the joint.

18. adding one of a plurality of bearing components to the inlay, each having a different thickness, to adjust laxity of the joint; The method of claim 11 further comprising:

19. adding one of a plurality of bearing components to the on-lay, each having a different thickness, to adjust laxity of the joint; The method of claim 11 further comprising:

20. Inserting the broach assembly into the resected surface of the first bone of the joint comprises: inserting a pin into the resected surface; reaming an initial bore into the resected surface to accommodate a main body of the distal broach body; The method of claim 11 , comprising:

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