Device Dossier

Affinis Inverse Metaglene - Prosthesis, internal, joint, shoulder, total

Device Dossier for Affinis Inverse Metaglene - Prosthesis, internal, joint, shoulder, total (Prosthesis, internal, joint, shoulder, total, Class III,…

Intended purpose

The Affinis Inverse Metaglene forms part of the Affinis Inverse Shoulder System that is designed for treating rotator defect arthropathy, revision of a failed hemiprosthesis or total prosthesis in patients with rotator cuff defect and certain tumour-related modifications of the proximal humerus.

Functional description

The Affinis Inverse Metaglene is an eccentric metaglene to reduce inferior notching systematically and has 2 peg fixation for high primary stability.

TGA Public Summary