Device Dossier
R3 Biolox Delta Ceramic Acetabular Liners - Ceramic acetabular liner
Device Dossier for R3 Biolox Delta Ceramic Acetabular Liners - Ceramic acetabular liner (Ceramic acetabular liner, Class III, sponsor Smith & Nephew).…
- GMDN category: Ceramic 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.
Functional description
The sterile, alumina zirconia liner is placed into an acetabular shell and seated with an impactor and mallet. It provides an articulating surface for the acetabular prosthesis to interface with a ceramic Biolox Delta femoral head prosthesis during total hip arthroplasty. The liner features an outer titanium ring offering greater protection against chipped edges and tensile forces.