Device Dossier

Comprehensive Shoulder System Primary Micro Length Stem - Coated shoulder humeral stem prosthesis

Device Dossier for Comprehensive Shoulder System Primary Micro Length Stem - Coated shoulder humeral stem prosthesis (Coated shoulder humeral stem…

Intended purpose

The Comprehensive Shoulder System Primary Micro Length Stem is intended for use as a component of a shoulder replacement prosthesis. Indications Include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. Rheumatoid arthritis. Revision where other devices or treatments have failed. Correction of functional deformity. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Functional description

Humeral Stem component of a shoulder joint replacement prosthesis that is made from titanium alloy with a PPS porous plasma spray coating proximally to enhance biological fixation. Contains a 45/135 degree neck angle with a reverse morse taper to allow increased access to the glenoid and conversion to the Comprehensive Reverse Shoulder. Indicated for uncemented or cemented use.

TGA Public Summary