Device Dossier

Arthrex® UNIVERS™ II Humeral Stem - Uncoated shoulder humeral stem prosthesis

Device Dossier for Arthrex® UNIVERS™ II Humeral Stem - Uncoated shoulder humeral stem prosthesis (Uncoated shoulder humeral stem prosthesis, Class III,…

Intended purpose

The Arthrex UNIVERS II Humeral Stem 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 artificial non-monoblock/modular metal sterile implantable device for placement within the proximal humerus for attachment to a humeral head in shoulder joint replacement.

TGA Public Summary