Device Dossier

Arthrex® Universal Glenoid™ Central Screw - Reverse shoulder prosthesis

Device Dossier for Arthrex® Universal Glenoid™ Central Screw - Reverse shoulder prosthesis (Reverse shoulder prosthesis, Class III, sponsor Arthrex).…

Intended purpose

The Arthrex® Universal Glenoid™ Central Screw is intended for use with the Univers Revers shoulder prosthesis system in reverse total shoulder arthroplasty. The Universal Glenoid is indicated 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. The Universal Glenoid 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

Arthrex® Universal Glenoid™ Central Screw is used to provide primary fixation of the baseplate to the bone within the glenoid.

TGA Public Summary