Device Dossier

SYSTEM 12 CROSSFIRE ACETABULAR INSERT - Non-constrained polyethylene acetabular liner

Device Dossier for SYSTEM 12 CROSSFIRE ACETABULAR INSERT - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner,…

Intended purpose

A component of a total hip joint prosthesis that is used to replace or repair the acetabulum. Indications: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis (except the OSTEOLOCK HA Acetabular Cup); Correction of functional deformity; Revision procedures where other treatments or devices have failed; and, Non-unions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Functional description

An Acetabular Insert designed to be the inner portion of a two?piece acetabulum prosthesis that is sterile and made of polyethylene (UHMWPE), with a Cobalt Chrome liner wire. Inserted into an Acetabular Shell/Cup, to articulate with an artificial Femoral Head as part of a Total Hip Arthroplasty (THA). The insert has a 12 position snap lock mechanism providing secure interface with the Acetabular Shell/Cup.

TGA Public Summary