Summary for ARTG Entry:
Smith & Nephew Pty Ltd - R3 Biolox Delta Ceramic Acetabular Liners - Ceramic acetabular liner
ARTG entry for
Medical Device Included Class III
Smith & Nephew Pty Ltd
PO Box 393, North Ryde, NSW, 1670
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Smith & Nephew Inc Orthopaedic Division
1450 E Brooks Road
Memphis, TN, 38116
United States Of America
1. R3 Biolox Delta Ceramic Acetabular Liners - Ceramic acetabular liner
Single Device Product
48055 Ceramic acetabular liner
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.
Acetabular liner component of the cementless R3 Acetabular System. 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 trauma or noninflammatory degenerative joint disease (NIDJD)
or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital
epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid
arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of
nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement
that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone
resection; fracture-dislocation of the hip; and correction of deformity.
Diameter (mm) Outer 48 to 66/68mm
Diameter (mm) Inner 32 or 36
No Specific Conditions included on Record
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