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…

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.

TGA Public Summary