Device Dossier

Affinis Inverse Inlay Spacer with Fixation Screw - Reverse shoulder prosthesis body

Device Dossier for Affinis Inverse Inlay Spacer with Fixation Screw - Reverse shoulder prosthesis body (Reverse shoulder prosthesis body, Class III,…

Intended purpose

The Affinis Inverse inlay spacer forms part of the Affinis Inverse Reverse 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 Spacer with Fixation Screw increases offset up to 24mm. In revision cases the offset of the inverse prosthesis sometimes has to be increased. The Affinis Inverse offers a spacer of 9mm that allows building increased offset up to 24 mm (2 spacer +6mm inlay). If 2 spacers are used the extra long separately packed fixation screw needs to be used. Both implants need to be secured mandatorily with a fixation screw by the use of the counter adaptor and moment key.

TGA Public Summary