Device Dossier

Bipolar Head SS - Metallic femoral head prosthesis

Device Dossier for Bipolar Head SS - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Enovis Surgical). ARTG…

Intended purpose

The stainless steel bipolar head is intended to treat fracture or avascular necrosis of the femoral head, or fracture of the femoral neck in cases where composition and morphology of the bone that allows the implant to remain stable

Functional description

The bipolar head includes a retaining ring. The external component is located in a fixed position in the natural acetabulum and the main articulating motion takes place in the form of a multi-dimensional rotational movement in the articular cavity between the inner head and the inside of the outer shell. In extreme cases there is a sliding movement of the outer shell on the acetabular cartilage. The bipolar principle thus reduces wear of the chondral tissue in the acetabulum.

TGA Public Summary