Device Dossier

Cobalt Chrome Head - Hip Femoral Head - Metallic femoral head prosthesis

Device Dossier for Cobalt Chrome Head - Hip Femoral Head - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Symbios…

Intended purpose

Metallic femoral heads are single-use implants, made of CrCoMo alloy (ISO5832/12) and designed to be assembled on a 12/14 Symbios stem taper. The implant is sterile and intended for primary total hip replacement.

Functional description

A femoral head made from chromium-cobalt alloy (CoCr) designed to be assembled with a femoral stem. It articulates with a polyethylene liner of an acetabular component. The finished surface of the metal head is mirror-polished

TGA Public Summary