Device Dossier

RESTORATION ADM Cup with HA - Acetabular shell

Device Dossier for RESTORATION ADM Cup with HA - Acetabular shell (Acetabular shell, Class III, sponsor Stryker). ARTG record, intended purpose, GMDN…

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. 6. Dislocation risks

Functional description

The Restoration Anatomic Dual Mobility (ADM) Acetabular Cup has a highly polished inner surface to help reduce wear between the cup and the insert and an anatomical shaped rim to limit cup impingement with the stem or the psoas muscle. The Restoration ADM acetabular cup is manufactured from Cobalt Chrome alloy with a commercially pure Titanium and Hydroxyapatite coating.

TGA Public Summary