Device Dossier

TRITANIUM HEMISPHERICAL Acetabular Shell - Acetabular shell

Device Dossier for TRITANIUM HEMISPHERICAL Acetabular Shell - Acetabular shell (Acetabular shell, Class III, sponsor Stryker). ARTG record, intended…

Intended purpose

A component of a total hip joint prosthesis that is used to replace or repair the acetabulum. 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 is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. The HOWMEDICA OSTEONICS TRITANIUM Acetabular Shell is intended for cementless use only.

Functional description

This Acetabular Shell is the outer portion of a two-piece acetabulum prosthesis. Sterile, made of Titanium with a Particle Sintered Foam (PSF) coating, is pressfit to the pelvis, without the use of cement. With option to use screws for additional fixation. Includes dome hole plug, threaded into the dome hole to help seal the shell (optional). An Acetabular Insert is implanted within to provide an articulating surface for an artificial Femoral Head/Stem, part of a Total Hip Arthroplasty.

TGA Public Summary