Device Dossier
Uncoated femoral stem prosthesis, modular
Device Dossier for Uncoated femoral stem prosthesis, modular (Uncoated femoral stem prosthesis, modular, Class III, sponsor Smith & Nephew). ARTG record,…
- GMDN category: Uncoated femoral stem prosthesis, modular
- Sponsor: Smith & Nephew
Intended purpose
The femoral component of the CPCS Cemented Hip System is 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, cobalt-chrome femoral component of a total hip system. The CPCS femoral stem is intended to be used in primary total hip replacement and features a tapered geometry, trapezoidal cross-section, highly polished surface, a 12/14 taper and is intended to be used with bone cement.