Device Dossier
Fitmore™ Shells w Screw Cones - Acetabular shell
Device Dossier for Fitmore™ Shells w Screw Cones - Acetabular shell (Acetabular shell, Class III, sponsor Zimmer Biomet). ARTG record, intended purpose,…
- GMDN category: Acetabular shell
Intended purpose
Fitmore shells used together with a compatible insert are indicated for uncemented use as the acetabular component in total or hemi hip arthroplasty for replacing the hip joint of patients suffering severe pain or disability (Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis; patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed hip arthroplasty) provided there is an adequate bone stock to support the cementless fixation of the acetabular shell.
Functional description
An acetabular shell component intended to provide an articulating surface in conjuction with a liner component as part of an acetabular hip system for the treatment of degenerative diseases or trauma of the hip. It is a a cup with sharp-edged screw cones, through which insertion of cancellous screws is possible for maximising mechanical stability. The basic raw material used for manufacturing of the Fitmore Shells is cpTi (Sulmesh®-Ti, Protasul®-Ti)