Device Dossier

Logical Ceramic Liner - Ceramic acetabular liner

Device Dossier for Logical Ceramic Liner - Ceramic acetabular liner (Ceramic acetabular liner, Class III, sponsor Signature Orthopaedics). ARTG record,…

Intended purpose

The Logical Ceramic Liner is intended to replace the articular surface of the patient's acetabulum when used together with an acetabular shell from the Signature Orthopaedics' hip replacement range, to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis · Inflammatory joint disease including rheumatoid arthritis (excluding TSI stem) · Correction of functional deformity including congenital hip dysplasia · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture · Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Functional description

The Logical Ceramic Liner connects to an acetabular shell and provides an articular surface for a femoral head as part of a total hip joint replacement. The device is manufactured from Biolox Delta ceramic.

TGA Public Summary