Device Dossier

ACCOLADE HFx - Press-fit hip femur prosthesis, one-piece

Device Dossier for ACCOLADE HFx - Press-fit hip femur prosthesis, one-piece (Press-fit hip femur prosthesis, one-piece, Class III, sponsor Stryker). ARTG…

Intended purpose

A component of a total hip joint prosthesis that is used to replace the femoral neck. The indications for use for total hip and hemi hip arthroplasty include: 1. non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Functional description

A sterile implantable one piece Femoral Hip Stem designed to replace the proximal femoral neck as part of a Hip Arthroplasty (Available 127 Degree Neck Angle). A circumferential titanium plasma spray surface over the proximal body assists with mechanical engagement in bone. Intraoperatively assembled with a Femoral Head. Made of Cobalt Chrome and intended for use without cement.

TGA Public Summary