Device Dossier

Arthrex® Univers Revers™ Modular Glenoid System Monoblock Post Baseplate - Reverse shoulder prosthesis base plate

Device Dossier for Arthrex® Univers Revers™ Modular Glenoid System Monoblock Post Baseplate - Reverse shoulder prosthesis base plate (Reverse shoulder…

Intended purpose

The Arthrex® Univers Revers™ Modular Glenoid System Monoblock Post Baseplate 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. The Univers Revers Modular Glenoid System is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.

Functional description

Arthrex® Univers Revers™ Modular Glenoid System Monoblock Post Baseplate to be attached to the glenoid to serve as the foundation of the glenosphere. It is a one-piece baseplate that incorporates a post. The backside of the baseplate and the incorporated post has a porous BioSync coating for bone and tissue ingrowth. It has peripheral screw holes that accommodate locking and nonlocking screws.

TGA Public Summary