Shoulder Replacement System-Glenoid peg - India CDSCO Medical Device Registration

Product Information

The GLOBAL Shoulder System is indicated for use in total or hemi-shoulder replacement for the treatment of:1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; 2. Fracture-dislocations 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; 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (LPS). The GLOBAL Shoulder System is also indicated for hemi-shoulder replacement for the treatment of: 1. Ununited humeral head fractures; 2. Avascular necrosis of the humeral head. The Humeral Stems when used with a GLOBAL Humeral Head and the GLOBAL Humeral Stem when used with a GLOBAL Humeral Head are indicated for hemi-shoulder replacement in patients with rotator cuff tears. The GLOBAL Shoulder System is indicated for the following fixation methods: 1) POROCOAT Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating. 2) Cemented Components - Humeral Stem and Glenoid components labeled “For cemented use only” are indicated only for use with bone cement. 3) Press-fit or Cemented Components - Humeral stem prosthesis without porous coating and labeled “For press-fit or cemented use only” are indicated for press-fit uncemented use or for use with bone cement. The GLOBAL Resurfacing Shoulder Humeral Heads are intended as a total or hemi-shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation. The GLOBAL Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory degenerative joint disease (LPS), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis. The GLOBAL Resurfacing Shoulder Humeral Heads are intended for uncemented use only