Device Dossier
Redapt Cemented XLPE Liners - Non-constrained polyethylene acetabular liner
Device Dossier for Redapt Cemented XLPE Liners - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class III,…
- GMDN category: Non-constrained polyethylene acetabular liner
- Sponsor: Smith & Nephew
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, 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 REDAPT Cemented Liners are to be implanted with bone cement. The REDAPT Fully Porous Shell and REDAPT Cemented Liner combination is for use in complex primary and revision surgeries only. In Australia, the REDAPT Acetabular System is indicated for revision surgery only.
Functional description
The Redapt Cemented XLPE Liner has machine grooves on the non-articulating surface to interface with bone cement. The non-articulating surface also has integral polyethylene spheres that extend from the surface to ensure a consistent 1.5mm cement mantle. The liners are designed to work with Redapt Porous Acetabular Shell