Device Dossier

SMR Glenosphere CoCrMo - Reverse shoulder prosthesis head

Device Dossier for SMR Glenosphere CoCrMo - Reverse shoulder prosthesis head (Reverse shoulder prosthesis head, Class III, sponsor Enovis Surgical). ARTG…

Intended purpose

The Reverse Glenosphere is a component of the SMR Shoulder System that is intended for partial, primary or revision shoulder replacement in patients suffering from disability due to non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; treatment of acute fractures of the humeral head; revision of a failed primary.

Functional description

The Glenosphere (CoCrMo) is coupled with the Metal Back Glenoid and is for uncemented use.

TGA Public Summary