Device Dossier

SMR Revision Stem Ti6Al4V Uncemented - Coated shoulder humeral stem prosthesis

Device Dossier for SMR Revision Stem Ti6Al4V Uncemented - Coated shoulder humeral stem prosthesis (Coated shoulder humeral stem prosthesis, Class III,…

Intended purpose

The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: 1) non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods; 4) revision of a failed primary implant.

Functional description

Revision Humeral Stem designed to provide fixation within the proximal humerus and a site of attachment either a humeral body or a reverse humeral body to position a Glenosphere or humeral head onto to provide articulation in a shoulder joint replacement.

TGA Public Summary