Device Dossier

Biolox Delta Ceramic Revision Femoral Head - Ceramic femoral head prosthesis

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

Intended purpose

The BIOLOX Delta ceramic revision femoral heads paired with TA6V ELI sleeves are designed for revision hip procedures for 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 femoral head is stronger, scratch resistant and has good wear properties. It can be used in combination with polyethylene or suitable ceramic inserts. The head can be used with all Amplitude femoral stems (when the neck of the stem is in good without having to change the stem). The revision femoral heads paired with sleeves are for revisions preserving the stem and the neck. The revision heads and sleeves are manually assembled together and combined on 10/12 neck stems.

TGA Public Summary