Device Dossier
RESTORATION ADM / MDM X3 Insert - Prosthesis, internal, joint, hip, acetabular component
Device Dossier for RESTORATION ADM / MDM X3 Insert - Prosthesis, internal, joint, hip, acetabular component (Acetabulum prosthesis, Class III, sponsor…
- GMDN category: Acetabulum prosthesis
- 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 arthroplasty include: 1. Noninflammatory 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. 6. Dislocation risks RESTORATION ADM HA Cups and MDM Liners are intended for cementless use only.
Functional description
The ADM/MDM inner acetabular polyethylene inserts are made from a Ultra High Molecular Weight Polyethylene (UHMWPE) and are available with an inner diameter that accommodates the mating femoral head. The inserts used with the cups are designed to move freely in the cup.