Device Dossier

Arthrex® UNIVERS™ II Humeral Head - Humeral head prosthesis

Device Dossier for Arthrex® UNIVERS™ II Humeral Head - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Arthrex). ARTG record,…

Intended purpose

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.

Functional description

An uncoated artificial humeral head designed to be attached to a humeral stem prosthesis and to articulate against an artificial or natural glenoid fossa.

TGA Public Summary