Device Dossier

Comprehensive Reverse Shoulder System Vivacit-E Bearing - Reverse shoulder prosthesis cup

Device Dossier for Comprehensive Reverse Shoulder System Vivacit-E Bearing - Reverse shoulder prosthesis cup (Reverse shoulder prosthesis cup, Class III,…

Intended purpose

The Comprehensive Reverse Shoulder System Vivacit-E Bearing is a component of the Comprehensive Reverse Shoulder System which is 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. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Functional description

The Comprehensive R Vivacit E Mini Humeral bearing has a 12° angle, making the neck-shaft angle 57° and attaches to either the new Mini Ti or Mini CoCr Humeral Tray using new Snap-Fit mechanism feature. The under-side is shaped with a circular protrusion with two flattened sides; these flattened sides provide an anti-rotation mechanism to ensure bearing latches into correct positioning on the humeral tray. Made from ultra-high molecular weight polyethylene/Vitamin E.

TGA Public Summary