Shoulder System- Epiphyseal Component - India CDSCO Medical Device Registration

Product Information

The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total or hemishoulder arthroplasty in treatment of the following: • A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis • Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory • Irreducible 3- and 4-part fractures of the proximal humerus • Ununited humeral head fractures • Avascular necrosis of the humeral head • Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (Corail) Hemi-shoulder arthroplasty is also indicated for: • Deformity and/or limited motion GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND™ Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(Corail), and a functional deltoid muscle is necessary to use the device. When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use