Device Dossier
REFLECTION All-Poly XLPE Cup - Polyethylene acetabulum prosthesis
Device Dossier for REFLECTION All-Poly XLPE Cup - Polyethylene acetabulum prosthesis (Polyethylene acetabulum prosthesis, Class III, sponsor Smith &…
- GMDN category: Polyethylene acetabulum prosthesis
- 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
The sterile, cross-linked polyethylene acetabular prosthesis is designed to maximize stability and durability. The outer surface is designed to improve the bond strength of the polyethylene to cement to bone interface through radial ridges and polar grooves. A 20 degree overhang provides additional coverage and joint stability. The cup is positioned with a cup positioner and inserted following cement compression.