Device Dossier
Cerasul® Head Taper 12/14 - Ceramic femoral head prosthesis
Device Dossier for Cerasul® Head Taper 12/14 - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Zimmer Biomet). ARTG…
- GMDN category: Ceramic femoral head prosthesis
Intended purpose
Cerasul Head Taper 12/14 are indicated to be used as modular components for THA in combination with other components as approved by Zimmer GmbH for replacing the hip joint of patients suffering severe pain or disability (Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis as well as trauma or post-traumatic osteoarthritis).
Functional description
Cerasul Head Taper 12/14 are a modular component used for articulation in Total Hip Arthroplasty. The articulation is comprised of a femoral head and a corresponding insert or cup respectively. Ceramic Femoral Heads are available in 28mm diameters and are to be used in combination with Polyethylene or with suitable Ceramic inserts/cups. Intended for single use only.