Device Dossier

Arthrex® Univers Revers™ Non-Locking Peripheral Screw - Reverse shoulder prosthesis

Device Dossier for Arthrex® Univers Revers™ Non-Locking Peripheral Screw - Reverse shoulder prosthesis (Reverse shoulder prosthesis, Class III, sponsor…

Intended purpose

Arthrex® Univers Revers™ Non-Locking Peripheral Screw 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™ Non-Locking Peripheral Screw is used to provide fixation of the baseplate to the bone within the glenoid.

TGA Public Summary