Device Dossier

Delta Ceramic Femoral Head - Ceramic femoral head prosthesis

Device Dossier for Delta Ceramic Femoral Head - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor DePuy Synthes). ARTG…

Intended purpose

The Delta Ceramic Femoral Head is part of a total hip prosthesis. Total hip arthroplasty 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 Femoral Head is made from Biolox ceramic (alumina composite) and fixes onto a femoral stem with corresponding tapered neck.

TGA Public Summary