Device Dossier

Comprehensive Total Shoulder Humeral Fracture Stem with PPS - Coated shoulder humeral stem prosthesis

Device Dossier for Comprehensive Total Shoulder Humeral Fracture Stem with PPS - Coated shoulder humeral stem prosthesis (Coated shoulder humeral stem…

Intended purpose

Comprehensive Fracture Stem with Plasma Porous Spray as component for use in a total, reverse or partial shoulder replacements. Indications for use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Correction of functional deformity. 5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Indicated for either cemented or uncemented biological fixation applications.

Functional description

This stem is made of cobalt chrome alloy with Titanium alloy porous plasma spray coating at the proximal end, and smooth distal end for cement fixation. Two lateral fins with three suture holes and a single medial fin with one suture hole aid tuberosity fixation. Comprehensive Fracture stems are intended for use with the Bio-modular humeral heads and glenoid components and Versa-dial Humeral heads. Stems are 122mm long; available in 2 mm diameter increments

TGA Public Summary