Device Dossier

Arthrex® Univers Revers™ Spacer - Reverse shoulder prosthesis body

Device Dossier for Arthrex® Univers Revers™ Spacer - Reverse shoulder prosthesis body (Reverse shoulder prosthesis body, Class III, sponsor Arthrex).…

Intended purpose

Arthrex® Univers Revers™ Spacer 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

Arthrex® Univers Revers™ Spacer is an optional addition to the humeral cup prior to implantation of the liner to fine-tune soft tissue balancing.

TGA Public Summary