Device Dossier

SMR Humeral Head CoCrMo - Humeral head prosthesis

Device Dossier for SMR Humeral Head CoCrMo - Humeral head prosthesis (Humeral head prosthesis, Class III, sponsor Enovis Surgical). ARTG record, intended…

Intended purpose

The SMR Humeral Head is part of the SMR Shoulder System which is intended for partial or total, primary or revision shoulder joint replacement suffering from disability due to, non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, inflammatory degenerative joint disease such as rheumatoid arthritis, treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods and revision of a failed primary implant.

Functional description

The Humeral Head is made of CoCrMo and is attached to the humeral body via a humeral head adaptor and combined they provide articulation in the shoulder joint with the natural glenoid fossa or a replacement glenoid fossa prosthesis to provide movement.

TGA Public Summary