Device Dossier
Spectron EF Primary 12/14 Taper CoCr Femoral Component - Uncoated hip femur prosthesis; modular
Device Dossier for Spectron EF Primary 12/14 Taper CoCr Femoral Component - Uncoated hip femur prosthesis; modular (Uncoated hip femur prosthesis,…
- GMDN category: Uncoated hip femur prosthesis, modular
- Sponsor: Smith & Nephew
Intended purpose
A sterile cobalt-chrome femoral component of a total hip system intended to be used with 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 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 cobalt chrome alloy cemented femoral hip stem which features: a roughened proximal surface which increases the implant surface area leading to a stronger bond at the implant/cement interface; a polished circulotrapezoidal neck for increased range of motion of the joint and decreased impingement and dislocation; 12/14 taper compatibility with 12/14 taper femoral head; and, a rectangular cross section through the distal portion of the stem for rotational stability.