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The ReUnion RFX System includes a Reversible Fracture Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended use only. When used with ReUnion TSA Humeral & Glenoid Components The ReUnion RFX System, when used with ReUnion TSA Humeral and Glenoid components, is indicated for use as a Hemi or Total Shoulder Replacement: - · Aseptic necrosis of the humeral head. - · Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, or posttraumatic arthritis. - · Proximal humeral fractures and/or dislocation. - · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results. - · Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure. In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural grovides sufficient bone stock, ReUnion RFX humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion RFX humeral stems can be converted from a total or reverse shoulder arthroplasty as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate. The glenoid components are intended for cemented use only. When used with ReUnion RSA Humeral & Glenoid Components The ReUnion RFX System, when used with ReUnion RSA humeral & glenoid components, is intended for primary, fracture, or revision total shoulder replacement. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s). · Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis; - Proximal humeral fractures - · Revisions of previously failed shoulder joint replacements In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty. In conjunction with ReUnion RSA humeral and glenoid components, ReUnion RFX humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator cuff with severe arthropathy failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically suited to receive the implant(s). Glenoid Baseplate components are intended for cementless use with the addition of screw fixation. The ReUnion RSA Shoulder System is intended for primary, fracture, or revision of total Shoulder replacement. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implant(s). - · Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis or rheumatoid arthritis. - Proximal humeral fracture. - · Revision of previously failed shoulder joint replacement. Glenoid Baseplate components are intended for cementless use with the addition of screw fixation. The Humeral Stem components are intended for both cemented and cementless use. In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty. In conjunction with ReUnion RSA humeral and glenoid components, ReUnion TSA humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator ouff with sever arthropathy or previously failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s). For use as a Hemi or Total Shoulder Replacement · Aseptic necrosis of the humeral head. · Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or posttraumatic arthritis. • Proximal humeral fracture and/or dislocation. · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results. · Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure. Glenoid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use. In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural grovides sufficient bone stock, ReUnion TSA humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion TSA humeral stems can be converted from a total or ReUnion RSA reverse shoulder arthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market additional components to the ReUnion RSA, TSA and RFX Systems, previously cleared via K161863. ReUnion Reversible Fracture System (RFX) The ReUnion Reversible Fracture System consists of a humeral fracture stem component which may be used in conjunction with TSA or RSA humeral and glenoid components for conventional total shoulder arthroplasty or reverse shoulder arthroplasty. It may also be used in conjunction with TSA humeral components to articulate directly with the anatomic glenoid in a hemi-shoulder application. The device contains various number of suture holes. The stems have a female taper on the proximal end of the shaft to accept TSA and RSA Gleno-humeral components. It is designed to be used in cemented applications only. ReUnion Reverse Shoulder Arthroplasty System (RSA) The ReUnion RSA Shoulder System is a system of components intended for total shoulder replacement in a reverse shoulder configuration. The system is comprised of a humeral cup, humeral insert, glenosphere, glenoid baseplate and screws. The Humeral Cup with the Humeral Insert are attached to the humeral side of the joint via the ReUnion TSA Humeral Stem while the Glenosphere is implanted with the Glenoid Baseplate onto the glenoid side of the joint fixated with locking Center and Peripheral Screws. ReUnion Total Shoulder Arthroplasty System (TSA) The Reunion Total Shoulder Arthroplasty (TSA) System is intended for shoulder arthroplasty. The components of this system consist of humeral stems, a modular humeral neck adapter, single radius humeral heads, and self-pressurizing glenoids (SPG). The humeral stem is offered in both cemented and cementless designs. The cementless humeral stem design features a circumferential Ti-plasma spray and hydroxyapatite (HA) coating at the proximal end and the cemented humeral stems have no coating at the proximal end. These humeral stems were designed to mate with the subject single radius humeral heads or the modular neck adapter, for compatibility with other marketed humeral heads. The self-pressuring glenoids (SPG) mate with the single radius heads. The SPGs are offered in both pegged and keeled configurations.

The Stryker VariAx 2 Wrist Fusion System is indicated for wrist arthrodesis and fixation of fractures in patients with wrist arthritis or fractures of other small bones of the carpus. Specific indications include: - Post-traumatic arthritis of the joints of the wrist . - Rheumatoid wrist deformities requiring restoration ● - Complex carpal instability ● - Post-septic arthritis of the wrist ● - Severe unremitting wrist pain related to motion - Brachial plexus nerve palsies - o Tumor resection - Spastic deformities

VariAx 2 Wrist Fusion System is a fixation device that consists of plates with different design (standard bend, short bend, and straight) manufactured from Commercially Pure Titanium Grade 2 (ASTM F67). The plates will be available sterile and non-sterile. VariAx 2 Wrist Fusion System will be used with locking and non-locking screws (2.3mm, 2.7 and 3.5mm) previously cleared in K040022 (Stryker® Leibinger Universal Distal Radius System), K073527 (VariAx™ Elbow System), K080667 (VariAx™ Distal Radius Torx Screws), and K140769 (VariAx 2 System). VariAx 2 Wrist Fusion System will be used with new and existing instruments previously cleared in K101056 (VariAx Elbow System), K130009 (VariAx 2 Compression Plating System), and K140769 (VariAx 2 System).

The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include: · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures - · Non-unions and malunions - · Normal and osteopenic bone - · Osteotomies

This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market additional plates within the AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System includes anatomically contoured monoaxial locking plates. The 5.0mm System consists of the Distal Lateral Femur Plates (K123964). The 4.0mm System comprises the Proximal Lateral Tibia Plate, Proximal Medial Tibia Plate, Distal Medial Tibia and Distal Anterolateral Tibia Plate (K123964 & K141121). This submission adds the Proximal Lateral Humerus Plate to the 4.0mm System of the AxSOS 3 Ti Locking Plate System. The system includes three (3) types of screws available in various diameter and thread length: locking, cortical, and cancellous (K 123964 & K133440). The plates have been designed with holes that can accommodate either a locking or non-locking screw at the peri-articular end and along the shaft of the plates also have an oblong hole located at the metaphyseal junction used to aid in positioning. The subject components will be available sterile and non-sterile. The associated accessories include: - Aiming Block, Proximal Lateral Humerus, Right ● - . Aiming Block, Proximal Lateral Humerus, Left - X-Ray Template, Proximal Lateral Humerus ● - Tag for Proximal Humerus Plate Insert ● - . Proximal Lateral Humerus Insert

The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of: - Open and Closed Fractures - Post-traumatic joint contracture which has resulted in loss of range of motion - Fractures and disease which generally may result in joint contractures or motion and fractures requiring distraction - Pseudoarthrosis or non-union of long bones - Limb lengthening by epiphyseal or metaphyseal distraction - Correction of bony or soft tissue deformity - Correction of segmental bony or soft tissue defects - Joint arthrodesis - Management of comminuted intra-articular fractures of the distal radius The Stryker Hoffmann LRF System is indicated in adults for: - Osteotomy - Revision procedure where other treatments or devices have been unsuccessful - Bone reconstruction procedures - Fusions and replantations of the foot - Charcot foot reconstruction - Lisfranc dislocations

Originally cleared in K113327, the Hoffmann LRF System is an external fixation device that consists of carbon and aluminum full/open rings and ring segments, aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolt offset adapters, pin bolts and pin adapters, and washers. Modifications to the previously cleared telescopic strut and wire bolt components, as part of the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327, were cleared in K130334. Additional components (carbon foot ring, foot arch, hinge coupling) were cleared in K130907 as a line extension to the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327. This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the inclusion of additional components to the previously cleared Hoffmann LRF (Limb Reconstruction Frame) System, in K130907. The additional components of this submission will consist of the following: constrained hinge strut, universal hinge strut, motor struts, spherical washer, hinge bolt, self-locking nut, half hinge, universal joint, adjustment instrument, slotted plate and buckle. This external fixation system may also be used with the components of other Stryker Trauma AG external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II, Hoffman II MRI and Hoffmann 3 External Fixation System, and the Apex Fixation Pins.

The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Including: · Replantation - · Joint fusions - · Corrective osteotomies - · Osteopenic bone

This Special 510(k) submission is being supplied to the U.S. FDA seeking clearance for additional compatibility between the previously cleared VariAx 2 System (K140376) and previously cleared VariAx 2 System screws (K132502 and K140769). The previously cleared screws include the T8 Ø2.4mm, T10/T8 Ø2.7mm, and T10 Ø3.5mm screws. The VariAx 2 System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures and corrective procedures in the foot and ankle.

The VariAx Elbow Plating System is intended for fracture fixation of long bones. The distal humerus plates are indicated for: • intra-articular or extraarticular fractures of the distal humerus • osteotomies • nonunions The olecranon plates are indicated for: • intra-articular or extraarticular fractures of the proximal ulna • osteotomies • nonunions

This Traditional 510(k) submission is being supplied to the U.S. Food and Drug Administration to provide authorization to market a line extension to the VariAx Elbow Plating System, which was previously cleared in the VariAx Elbow Plating System (K073527 & K101056). The VariAx Elbow Plating System consists of washers, screws, and plates. This submission is intended to introduce 2 & 3-hole plates to the Lateral and Posterior Lateral plate range as well as 3-hole plates to the Posterior Medial, Medial Extended and the Olecranon plate ranges. All of the plates except for the Olecranon plates are Distal Humerus plates. The subject plates are fixed to the distal humerus and Olecranon using 2.7mm or 3.5mm locking or non-locking screws. These screws were cleared in K073527, K101056, K132502 and K140769. The subject plates are available sterile and non-sterile. The subject and predicate plates are manufactured from Titanium Alloy per ASTM F136 and Commercial Pure Titanium per ASTM F67.

The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include: • Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures • Non-unions and malunions • Normal and osteopenic bone • Osteotomies • Periprosthetic fractures of the femur and proximal tibia

This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market additional plates and screws within the AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System includes anatomically contoured monoaxial locking plates. The 5.0mm System consists of the Distal Lateral Femur Plate (K123964). The 4.0mm System comprises the Proximal Lateral Tibia Plate (K123964) as well as the subject devices being the Distal Anterolateral Tibia Plate, the Distal Medial Tibia Plate and the Proximal Medial Tibia Plate. The system includes four (4) types of screws available in various diameter and thread length: locking, cortical, cancellous (K123964 & K133440) as well as the subject periprosthetic screws. The plates have been designed with holes that can accommodate either a locking or non-locking screw both at the peri-articular end and along the shaft of the plates also have an oblong hole located at the metaphyseal junction used to aid in positioning. The subject components will be available sterile and non-sterile.

The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of bones in adult patients. The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. Indications include the following: osteotomies and non-unions, fixation of fractures, normal bone density and osteopenic bone.

The VariAx 2 One-Third Tubular Plating System is an internal fixation device that consists of straight plates used with compatible screws to fit different types of fractures in the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. The subject components will be available sterile. The plates will be available in sizes ranging from 23-191mm in length.

The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications: - osteotomies, mal-unions, and non-unions . - single, segmental, and comminuted fractures . - normal bone density and osteopenic bone .

The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-246mm in length.