Device Dossier

REFLECTION Constrained Liner - Constrained polyethylene acetabular liner

Device Dossier for REFLECTION Constrained Liner - Constrained polyethylene acetabular liner (Constrained polyethylene acetabular liner, Class III,…

Intended purpose

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip deformity.

Functional description

The sterile, ultra high molecular weight polyethylene liner is seated into an acetabular shell with an impactor and mallet following insertion of the Reflection Constrained Liner Adaptor. A retaining ring is placed over the femoral head and is seated after the femoral head is inserted, holding the femoral head in position.

TGA Public Summary