Device Dossier

Affinis Fracture Head Bionit - Prosthesis, internal, joint, shoulder, total

Device Dossier for Affinis Fracture Head Bionit - Prosthesis, internal, joint, shoulder, total (Prosthesis, internal, joint, shoulder, total, Class III,…

Intended purpose

The Affinis Fracture Head forms part of the Affinis Fracture Shoulder System that is designed for use in multi-fragment and comminuted fractures of the humeral head, fractures of the proximal humerus that cannot be treated with osteosynthesis, secondary fragment dislocation following osteosynthesis in the proximal humerus in order to retain the joint function and in certain tumourrelated modifications of the proximal humerus.

Functional description

The Affinis Fracture Head is manufactured from a biologically inert ceramic and is designed to be used with the Affinis Fracture System that is designed for anatomical-biological healing.

TGA Public Summary