Device Dossier

Medacta Shoulder System Glenosphere - Reverse shoulder prosthesis head

Device Dossier for Medacta Shoulder System Glenosphere - Reverse shoulder prosthesis head (Reverse shoulder prosthesis head, Class III, sponsor Medacta).…

Intended purpose

Device indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement. 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation.

Functional description

The glenosphere is attached to the glenoid baseplate and secured by a taper connection and a fastening screw. The centre of the glenosphere is located at 4 or 9mm lateral to the deepest point of the reamed glenoid vault, while the inferior eccentricity is fixed at 2mm throughout the whole glenosphere range. The inferior offset reduces the risk of scapular notching, while the two options of lateralization allow the surgeon to select the desired level of ROM and joint tension.

TGA Public Summary