Device Dossier

Affinis Inverse Revision Stem Cemented - Reverse shoulder prosthesis body

Device Dossier for Affinis Inverse Revision Stem Cemented - Reverse shoulder prosthesis body (Reverse shoulder prosthesis body, Class III, sponsor Enovis…

Intended purpose

The Affinis Inverse cemented revision stem 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 cemented revision stem is designed to be used with bone cement for fixation and has a neck shaft angle of 155 degrees. The stems are long and extra long for revision shoulder procedures. The component is manufactured from Titanium Alloy (TiAl6V4).

TGA Public Summary