Device Dossier

BIOLOX® Delta Ceramic Femoral Heads (D Heads) - Ceramic femoral head prosthesis

Device Dossier for BIOLOX® Delta Ceramic Femoral Heads (D Heads) - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor…

Intended purpose

Biolox Delta Ceramic Femoral Heads (D Heads) are intended to be used in the following medical conditions: Osteoarthritis (primary and secondary),Femoral neck fracture, Necrosis of the femoral head, Dysplasia, Revision in case of breakage of a ceramic component when used with a ceramic liner.

Functional description

The “"D" femoral heads are intended for use in full hip replacements to reduce pain and restore hip joint mobility.

TGA Public Summary