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,…
- GMDN category: Humeral head prosthesis
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.