Device Dossier
Femoral stem centralizer
Device Dossier for Femoral stem centralizer (Femoral stem centralizer, Class IIb, sponsor Smith & Nephew). ARTG record, intended purpose, GMDN category —…
- GMDN category: Femoral stem centralizer
- Sponsor: Smith & Nephew
Intended purpose
A sterile implantable device placed onto the distal end of a cemented femoral stem being part of a total hip system. The distal centralizer assists in providing neutral alignment and a predictable cement mantle. 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.