Device Dossier

SYNERGY Porous Plus HA Femoral Component - Coated femoral stem prosthesis, modular

Device Dossier for SYNERGY Porous Plus HA Femoral Component - Coated femoral stem prosthesis, modular (Coated femoral stem prosthesis, modular, Class…

Intended purpose

A sterile femoral component of a total hip system. The Synergy Porous Plus HA femoral component is designed to mate with a femoral head and is intended to be used without bone cement. It is available in either standard or high offsets. 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. SYNERGY Hip Systems is for primary surgeries only.

Functional description

A titanium alloy femoral stem with a porous, hydroxyapatite coated surface, circulotrapezoidal neck, and optimized 12/14 taper. The device achieves rotational stability through extended anterior/posterior fins increasing the press-fit. Following femoral osteotomy, the femoral canal is sequentially rasped and the calcar is reamed. A trial reduction is then performed. The stem is seated using a stem inserter and mallet. The femoral head is then placed onto the neck taper and impacted.

TGA Public Summary