Device Dossier
Restoration Anatomic Shell - Acetabular shell
Device Dossier for Restoration Anatomic Shell - Acetabular shell (Acetabular shell, Class III, sponsor Stryker). ARTG record, intended purpose, GMDN…
- GMDN category: Acetabular shell
- Sponsor: Stryker
Intended purpose
An acetabular cup intended for use in primary and revision total hip arthroplasty and are intended for cementless fixation. Indicated for ;• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumaticarthritis 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. When used with MDM Liners • Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. • Dislocation risks When used with Constrained Liners • The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
Functional description
Metal acetabular shell manufactured from Titanium Alloy (Ti-6Al-4V ELI), a porous coating made of Pure Titanium. Multiple screw hole options located in the superior and inferior regions to allow for screw fixation.An offset center of rotation ranging from 3.5mm - 8mm designed to help manage a high hip center and reproduce normal joint biomechanics. A dome hole plug is available to seal the shell. The superior area of the shell, outside of the locking mechanism, has a recessed or beveled surface.