A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System

Inclusion Criteria

• •Subject is willing to sign the informed consent.
• •Subject is willing and able to comply with postoperative scheduled clinical evaluations.
• •Subject is male or non-pregnant female and 18 years or older at the time of surgery.
• •When used with ReUnion Total Shoulder Arthroplasty (TSA)Humeral \& Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement, subject has one or more of the following:
• •* Aseptic necrosis of humeral head;
• •* Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
• •* Proximal humeral fracture and/or dislocation;
• •* Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results;
• •* Previous unsuccessful total shoulder replacement, resurfacing or other procedure
• •When used with ReUnion RSA Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement, subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant, and subject has one or more of the following:
• •* Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis;
• •* Proximal humeral fracture
• •* Previously failed shoulder joint replacement