Global AP 135 Degree Taper Assembly - Press-fit shoulder humeral stem prosthesis

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Class:

Class III

Manufactured by:

DePuy Ireland UC Loughbeg Ringaskiddy, Co Cork Ireland

Therapeutic area:

48090 - Press-fit shoulder humeral stem prosthesis

Therapeutic indications:

The Global AP 135 Degree Taper Assembly is made from Titanium and is impacted onto the humeral stem. The selected head is then placed onto the impacted 135 Degree taper. The 135 Degree taper enables the assembled prosthesis to achieve a fixed 135 degree angle. The Global AP 135 Taper Assembly is one component of the Global AP Shoulder System which is intended for total or hemi shoulder arthroplasty. Total Shoulder or hemi-shoulder replacement is indicated for: 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 (e.g. revision of a failed primary component). Hemi-shoulder replacement is also indicated for: 1. Ununited humeral head fractures. 2. Avascular necrosis of the humeral head. 3. Rotator cuff tear arthropathy. 4. Deformity and/or limited motion.

Authorization status:

A

Authorization date:

2014-06-11