Device Dossier

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

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

Intended purpose

The Affinis Inverse Inlay 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 Inlay avoids PE debris at scapular neck, therefore reducing the danger of osteolysis and the design includes an 8° chamfer to reduce notching

TGA Public Summary