Device Dossier

Modular Hybrid Glenoid Base - Prosthesis, internal, joint, shoulder, glenoid component

Device Dossier for Modular Hybrid Glenoid Base - Prosthesis, internal, joint, shoulder, glenoid component (Prosthesis, internal, joint, shoulder, glenoid…

Intended purpose

The Modular Hybrid Glenoid Base is part of the Comprehensive Shoulder System and is intended for partial or total shoulder joint arthroplasty. Indications for use 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

Modular hybrid glenoid base component shoulder joint replacement prostheses. Made from UHMWPE/TI-6AL-4V Alloy. Available in three base sizes with three variations in glenoid fixation. Non-conforming diameter of curvature provides the ability to use any size head with any size glenoid. If the device is used with the optional porous titanium peg bone cement should not be used. If using the optional polyethylene peg it should be inserted with bone cement.

TGA Public Summary