Device Dossier
RSP Bone Screw – Non-Locking - Shoulder prosthesis screw
Device Dossier for RSP Bone Screw – Non-Locking - Shoulder prosthesis screw (Shoulder prosthesis screw, Class III, sponsor Enovis Surgical). ARTG record,…
- 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
A sterile component of a reverse shoulder prosthesis. The non-locking screws provide additional fixation of the glenoid baseplate to the glenoid surface. The screws are intended for angled placement in any direction up to 12 degrees, and should only be used when the perpendicular will not permit adequate bone purchase. The screws are made from titanium alloy.