Device Dossier
REFLECTION HA POROUS COATED ACETABULAR SHELL - 0/3 HOLES - Acetabular shell
Device Dossier for REFLECTION HA POROUS COATED ACETABULAR SHELL - 0/3 HOLES - Acetabular shell (Acetabular shell, Class III, sponsor Smith & Nephew).…
- GMDN category: Acetabular shell
- Sponsor: Smith & Nephew
Intended purpose
A titanium alloy porous coated plus HA acetabular shell being the outer portion of a two-piece acetabulum prosthesis intended to be used without bone cement. 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 trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Functional description
A sterile hemispherical acetabular porous-coated shell with non-animal derived hydroxyapatite to enhance stability. The shell may present with 0 or 3 holes. Prior to the insertion of the polyethylene liner, the apex hole is covered with a watertight threaded hole cover and any unused screw holes, if applicable are covered with hole cover which are impacted into place.