Device Dossier
RSP Retaining Screw, Replacement - Shoulder prosthesis screw
Device Dossier for RSP Retaining Screw, Replacement - Shoulder prosthesis screw (Shoulder prosthesis screw, Class III, sponsor Enovis Surgical). ARTG…
- GMDN category: Shoulder prosthesis screw
Intended purpose
A component of a reverse shoulder prosthesis system indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. 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.
Functional description
The retaining screw is a component of the Reverse Shoulder Prosthesis. The glenoid head is attached glenoid baseplate via morse taper connection. The glenoid heads have a 5.4mm diameter hole in the centre of the glenosphere to accept the 3.5mm titanium alloy retaining screw. The retaining screw is designed to be tightened into the central part of the glenoid base to provide an additional measure of security.