Device Dossier

Comprehensive Reverse Shoulder E1 Humeral Bearing - Reverse shoulder prosthesis cup

Device Dossier for Comprehensive Reverse Shoulder E1 Humeral Bearing - Reverse shoulder prosthesis cup (Reverse shoulder prosthesis cup, Class III,…

Intended purpose

A component of a reverse shoulder prosthesis system indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

Functional description

Polyethylene humeral bearing for reverse shoulder joint replacement prosthesis. Made from E1 antioxidant infused UHMWPE. Retentive bearings capture additional glenosphere surface. Includes a 12 degree angle and anti-rotation tabs.

TGA Public Summary