Device Dossier

Affinis Inverse metaglene CP - Reverse shoulder prosthesis

Device Dossier for Affinis Inverse metaglene CP - Reverse shoulder prosthesis (Reverse shoulder prosthesis, Class III, sponsor Enovis Surgical). ARTG…

Intended purpose

Device intended to restore the function of the shoulder and/or to relieve pain in skeletally mature patients. Indications include: • Grossly deficient rotator cuff with arthropathy or irreparable functional deformity • Revision of failed shoulder prosthesis or fracture treatment (conservative or surgical) with an irreparable rotator cuff • Tumour-related structural defects of the proximal humerus

Functional description

The Affinis Inverse metaglene CP (Central Peg) series has four anchoring peg lengths and the peg diameter is 8mm in coated condition. The design is completed by a screw and locking construct. In the anterior and posterior hole of the device the screws should be directed parallel to the peg. As needed the screws can be directed with an angular freedom by approximately ±8°. The superior and inferior screws can be rotated around the centre axis in the range of ±10° and are locked with a cap.

TGA Public Summary