Device Dossier

Comprehensive® VRS Glenoid Baseplate - Reverse shoulder prosthesis base plate

Device Dossier for Comprehensive® VRS Glenoid Baseplate - Reverse shoulder prosthesis base plate (Reverse shoulder prosthesis base plate, Class III,…

Intended purpose

The Biomet Comprehensive Vault Reconstruction System (VRS) Glenoid Component is intended for use as a component of the VRS system.The VRS system glenoid baseplate components are intended for cementless application with the addition of screw fixation in patients with unusual anatomy and/or extensive bone loss which precludes the use of a standard glenoid baseplate component. Biomet Comprehensive Vault Reconstruction System Components are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary

Functional description

The glenoid baseplate component of VRS System is for reverse shoulder arthroplasty and is designed to match the natural geometry of an individual patient. This patient-matched glenoid baseplate attaches to the glenoid bone with bone screws and is coupled with a glenosphere component via a taper adaptor component to allow reverse articulation with a polyethylene liner attached to a humeral component.

TGA Public Summary