Device Dossier

RSP Bone Screw - Locking - Shoulder prosthesis screw

Device Dossier for RSP Bone Screw - Locking - Shoulder prosthesis screw (Shoulder prosthesis screw, Class III, sponsor Enovis Surgical). ARTG record,…

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

A sterile component of a reverse shoulder prosthesis. The locking screws provide additional fixation of the glenoid baseplate to the glenoid surface. The screws are made from titanium alloy and intended for perpendicular placement.

TGA Public Summary