Device Dossier
REFLECTION XLPE 0/20 DEGREE LINER - Non-constrained polyethylene acetabular liner
Device Dossier for REFLECTION XLPE 0/20 DEGREE LINER - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner,…
- 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, 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
A sterile, cross-linked polyethylene (XLPE) acetabular liner seated into an acetabular shell with an impactor and mallet. Acetabular liners are designed for use only with acetabular shells from the same product family. Liners can vary in Degree of motion, Inner Diameter, Outer Diameter, Size and Type. Lateralized and Anteverted oriented liners present additional thickness of 4mm at the apex.