Device Dossier

Arthrex® Univers Revers™ Glenosphere - Reverse shoulder prosthesis head

Device Dossier for Arthrex® Univers Revers™ Glenosphere - Reverse shoulder prosthesis head (Reverse shoulder prosthesis head, Class III, sponsor…

Intended purpose

Arthrex® Univers Revers™ Glenosphere is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. It is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Functional description

A hemispherical component of the Arthrex® Univers Revers™ System is intended to be attached to the baseplate to articulate with a congruent reverse shoulder insert. The glenosphere is made of Cobalt Chromium alloy and contains a morse taper connection that mates with a taper on the baseplate components configurations reducing the risk of notching and increasing deltoid tension, improving the range of motion and stability.

TGA Public Summary