Device Dossier
ABG II Pack - Acetabular shell
Device Dossier for ABG II Pack - Acetabular shell (Acetabular shell, Class III, sponsor Stryker). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: Acetabular shell
- Sponsor: Stryker
Intended purpose
A component of a total hip joint prosthesis that is used to replace or repair the acetabulum. Indications include: • Noninflammatory 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, • Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
Functional description
The ABG II Pack contains a metal acetabular cup with HA and a ceramic insert. The cup provides stable fixation coupled with an even transfer of load to the supporting bone and promotes a secondary biological bonding between the implant and the surrounding bone. Acetabular shells are available with and without screw holes to enhance rotational stability. The insert is made of alumina which is abrasion and corrosion resistant resulting in excellent wear characteristics.