Device Dossier

UHR Universal Head Bipolar Component - Femoral head bipolar component

Device Dossier for UHR Universal Head Bipolar Component - Femoral head bipolar component (Femoral head bipolar component, Class III, sponsor Stryker).…

Intended purpose

Intended for use where femoral head/neck fractures or non-unions have occurred, in aseptic necrosis of the femoral head and osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Functional description

Intraoperatively assembled to femoral stem, bipolar component comprises of an outer shell in which a bearing insert is permanently assembled. Bearing insert has a factory installed retaining ring. Assembled prosthesis provides for primary articulation at the femoral head/inner polyethylene bearing interface and secondary articulation at the outer shell/acetabulum interface. Heads made from Cobalt-Chromium-Molybdenum Alloy and bearing inserts made from Ultra-High-Molecular-Weight Polyethylene.

TGA Public Summary