Device Dossier

ANTHOLOGY Porous - Coated hip femur prosthesis; modular

Device Dossier for ANTHOLOGY Porous - Coated hip femur prosthesis; modular (Coated hip femur prosthesis, modular, Class III, sponsor Smith & Nephew).…

Intended purpose

A sterile femoral component of a total hip system. It is designed to mate with either a femoral head or a femoral sleeve and modular head. It is intended to be used in primary total hip replacement and 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 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, trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

Functional description

A porous one-piece titanium alloy femoral component is inserted into a prepared femoral canal following femoral head osteotomy.The femoral canal is rasped with sequential broaches until it reaches the templated stem size.Following trial reduction with a broach/trial, standard or high offset neck trial, and femoral head trial, a stem inserter is used to rotate and place the stem. It is seated into the femur with a mallet femoral head is impacted on the neck taper.

TGA Public Summary