Device Dossier

ABG II Hooded Inserts - Prosthesis, internal, joint, hip, acetabular component

Device Dossier for ABG II Hooded Inserts - Prosthesis, internal, joint, hip, acetabular component (Acetabulum prosthesis, Class III, sponsor Stryker).…

Intended purpose

A component of a total hip joint prosthesis that is used to replace or repair the acetabulum. The indications for use for total hip and hemi hip arthroplasty include: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis (except the OSTEOLOCK HA Acetabular Cup and Peri-Apatite coated prostheses); 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

Is part of a total hip system that consists of a femoral stem, femoral head, acetabular shell, acetabular liner, and acetabular bone screws. The ABG II Hooded insert is a Ultra High Molecular Weight Polyethylene (UHMWPE) insert designed with a snap lock mechanism to securely lock into a metal acetabular shell. Available with varying inner diameters to help accommodate the mating femoral head.

TGA Public Summary