Device Dossier

OrthoCentric Head, BIOLOX® Delta ZTA Ceramic - Ceramic femoral head prosthesis

Device Dossier for OrthoCentric Head, BIOLOX® Delta ZTA Ceramic - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor…

Intended purpose

The OrthoCentric BIOLOX® Delta ZTA Ceramic Head is a component of a femoral system made of two components: a femoral stem and a BIOLOX® Delta ZTA Ceramic Head . It is supplied sterile. The OrthoCentric BIOLOX® Delta ZTA Ceramic Head is intended for use in total hip arthroplasty. Total hip arthroplasty (THA) is indicated for a hip joint replacement in order to provide increased patient mobility and reduce pain where there is evidence of sufficient sound bone to seat and support the components. Treatment selection for their patient is the surgeon’s responsibility. When a surgeon has selected total hip arthroplasty as the preferred treatment, the devices are indicated for: - Osteoarthritis or post traumatic osteoarthritis - Rheumatoid arthritis. - Correction of functional deformity. - Avascular necrosis of the femoral head or neck. - Acute traumatic fracture of the femoral head or neck. - Revision of any unsuccessful previous hip surgery or where other treatments or devices have failed. - Certain cases of ankylosis. - Hip dysplasia (painful or congenital) - Severely painful and/or disabled joint

Functional description

The OrthoCentric BIOLOX® Delta ZTA Ceramic Head connects to the neck of the femoral stem. Upon implantation, the assembly of these components is designed to replace the natural articulation of the hip joint.

TGA Public Summary