Arthrex? UNIVERS? II Humeral Head - Humeral head prosthesis

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Arthrex Australia Pty Ltd

Class:

Class III

Manufactured by:

Arthrex Inc 1370 Creekside Boulevard, Naples, Florida, 34108-1945 United States Of America

Therapeutic area:

48088 - Humeral head prosthesis

Therapeutic indications:

An uncoated artificial humeral head designed to be attached to a humeral stem prosthesis and to articulate against an artificial or natural glenoid fossa. The Arthrex UNIVERS II Humeral Head Shoulder Prosthesis is indicated in replacement(s) when conditions including severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

Authorization status:

A

Authorization date:

2018-08-30