Device Dossier

OrthoCentric Liner, BIOLOX® Delta ZTA Ceramic - Ceramic acetabular liner

Device Dossier for OrthoCentric Liner, BIOLOX® Delta ZTA Ceramic - Ceramic acetabular liner (Ceramic acetabular liner, Class III, sponsor OrthoCentric).…

Intended purpose

The OrthoCentric BIOLOX® Delta ZTA Ceramic Liner is a component of an acetabular system (cup) made of two components: an Acetabular Shell and a Liner. It is supplied sterile. The OrthoCentric BIOLOX® Delta ZTA Ceramic Liner 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 The acetabular components are intended for cementless fixation.

Functional description

The OrthoCentric BIOLOX® Delta ZTA Ceramic Liner is fitted into the acetabular shell. The inner surface of the liner is shaped to fit the new femoral head. The liner is available in a range of sizes. Upon implantation, the assembly of these components is designed to replace the natural articulation of the hip joint.

TGA Public Summary