Device Dossier

Biolox Delta Ceramic Femoral Head - Ceramic femoral head prosthesis

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

Intended purpose

Biolox Delta Ceramic femoral head for use in primary and revision total hip prosthesis surgery. Indications for use are: - Hip joint conditions due to degenerative or congenital, inflammatory, or post-traumatic causes - Sequelae from previous interventions, Total Hip Replacement, osteotomy, arthrodesis, bone reconstruction following tumour excision.

Functional description

The Biolox delta ceramic femoral head has greater resistance because of decrease grain size and increased density. It is scratch resistant and has good wear properties. It is an adaptive femoral head which can be used in combination with polyethylene or suitable ceramic inserts. The femoral head without sleeve can be used for revisions with change of the modular neck or change of the femoral stem. The head is placed on the stem taper by slightly twisting while pressing on the axis until seated.

TGA Public Summary