Device Dossier
Acetabular shell
Device Dossier for Acetabular shell (Acetabular shell, Class IIb, sponsor Stryker). ARTG record, intended purpose, GMDN category — compiled by arcimedes.
- GMDN category: Acetabular shell
- Sponsor: Stryker
Intended purpose
An acetabular cup/plate designed to stabilise a deficient acetabular. Indications: • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. • Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. • Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. • Segmental and/or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum, using standard total hip replacement acetabular components and procedures.