Device Dossier
Acetabular shell
Device Dossier for Acetabular shell (Acetabular shell, Class III, sponsor Smith & Nephew). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Acetabular shell
- Sponsor: Smith & Nephew
Intended purpose
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.
Functional description
A sterile shell of a two-piece cementless acetabulum prosthesis to be used with a liner which serves as the articulating surface. The outer surface of the titanium alloy (TI-6AL-4V) acetabular shell has a titanium porous coating to provide enhanced scratch-fit against cancellous and cortical bone. The shell is inserted into a prepared acetabulum with a shell inserter, impacted into place, and has the option of holes for additional screw fixation if required.