Device Dossier

Comprehensive Versa-Dial Reverse Shoulder System Glenosphere - Reverse shoulder prosthesis head

Device Dossier for Comprehensive Versa-Dial Reverse Shoulder System Glenosphere - Reverse shoulder prosthesis head (Reverse shoulder prosthesis head,…

Intended purpose

The Comprehensive Reverse Versa Dial Glenosphere 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

Comprehensive R Versa-Dial Glenosphere (40mM Diameter) is used in conjunction with humeral bearing and humeral tray component. It attaches to Glenosphere Baseplate through use of Standard or Mini Baseplate Taper Adapter that inserts into rear of Glenosphere. Features variable offsets which allow their use with the Versa-Dial Taper Adapter to allow surgeon to “dial in” an offset in order to adjust the center of rotation of the implant. Composed of cobalt-chrome alloy (contains Nickel).

TGA Public Summary