Device Dossier

Delta Ceramic Insert - Ceramic acetabular liner

Device Dossier for Delta Ceramic Insert - Ceramic acetabular liner (Ceramic acetabular liner, Class III, sponsor DePuy Synthes). ARTG record, intended…

Intended purpose

The Delta Ceramic Insert is the insert component in total hip arthroplasty and is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed, previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis.

Functional description

The Delta Ceramic insert is made out of biolox ceramic (alumina composite). The acetabulum is to be replaced with a DePuy acetabular component comprising either an UHMWPE cup or 2 piece metal shell with either an UHMWPE, metal or ceramic liner with an inside diameter corresponding to the outside diameter of the modular femoral that is utilized.

TGA Public Summary