Device Dossier
PE Acetabular Cup - Polyethylene acetabulum prosthesis
Device Dossier for PE Acetabular Cup - Polyethylene acetabulum prosthesis (Polyethylene acetabulum prosthesis, Class III, sponsor B Braun). ARTG record,…
- GMDN category: Polyethylene acetabulum prosthesis
- Sponsor: B Braun
Intended purpose
The polyethylene acetabular cup is intended to be used as a component of a human hip endoprosthesis in total hip arthroplasty procedures. The PE Acetabular Cup is indicated for use in treating acute disorders of the hip such as degenerative osteoarthritis, rheumatic arthritis, fractures of the joint and femoral head necrosis that cannot be treated by other therapies.
Functional description
The PE Acetabular Cup is made of ultra-high molecular low-pressure polyethylene with an x-ray contrast ring made of implant steel. It is designed to be used in combination with Aesculap hip endoprosthesis components for implantation with bone cement.