Device Dossier
OMNIFIT SERIES II 10° ACETABULAR INSERT - Non-constrained polyethylene acetabular liner
Device Dossier for OMNIFIT SERIES II 10° ACETABULAR INSERT - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular…
- GMDN category: Non-constrained polyethylene acetabular liner
- Sponsor: Stryker
Intended purpose
A component of a total hip joint prosthesis that is used to replace or repair the acetabulum. Indications • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic 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.
Functional description
This Acetabular Insert is the inner portion of a two-piece acetabulum prosthesis that is sterile and made of polyethylene (UHMWPE), with a Cobalt Chrome X-ray wire to help identify the cup position on an X-ray and to lock the insert to the Acetabular Shell. Inserted into an Acetabular Shell, to articulate with an artificial Femoral Head as part of a Total Hip Arthroplasty (THA).