Device Dossier
Plasmacup SC/MSC Biolox Delta Insert - Ceramic acetabular liner
Device Dossier for Plasmacup SC/MSC Biolox Delta Insert - Ceramic acetabular liner (Ceramic acetabular liner, Class III, sponsor B Braun). ARTG record,…
- GMDN category: Ceramic acetabular liner
- Sponsor: B Braun
Intended purpose
Used as a sterile implant to provide the articulating surface for the acetabulum prosthesis, after insertion into an acetabulum prosthesis shell, to interface with a femoral head prosthesis as part of a total hip replacement. To be used with acetabular cups for total hip arthroplasty.
Functional description
The Plasmacup SC/MSC Biolox Delta Inserts are to be used with Plasmacup acetabular cups for total hip arthroplasty. Biolox® delta, the latest generation of ceramics in THA, is a high strength aluminium oxide matrix ceramic. Finest ZiO2 particles represent the matrix material. The Plasmacup® liners are attached by a press-fit cone with a large surface area. After seating, the liner is fixed using an impactor with a plastic head.