Device Dossier

Affinis Fracture Inverse Central Part - Prosthesis, internal, joint, shoulder, total

Device Dossier for Affinis Fracture Inverse Central Part - Prosthesis, internal, joint, shoulder, total (Prosthesis, internal, joint, shoulder, total,…

Intended purpose

The Affinis Fracture Inverse 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 Fracture Inverse provides an intra-operative decision option for primary fracture. The component is manufactured from Cobalt Chrome Alloy (CoCrMo) and coated with titanium plasma spray (TPS) and Calcium Phosphate (CaP).

TGA Public Summary