Device Dossier

Biolox Delta Femoral Head - Ceramic femoral head prosthesis

Device Dossier for Biolox Delta Femoral Head - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Enovis Surgical).…

Intended purpose

Used to replace the anatomical the femoral head and is intended to be attach to the trunnion of a femoral stem component used in a total or hemi hip joint replacement. Also used for traumatic/reconstructive joint replacement in orthopaedic procedures.

Functional description

The Biolox Delta is a ceramic 12/14 Morse taper femoral head with mechanical and wear resistant capabilities. It is coupled together with a femoral neck.

TGA Public Summary