Summary for ARTG Entry:
Smith & Nephew Pty Ltd - REFLECTION XLPE 0 Degree Liner - Non-constrained polyethylene acetabular
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. REFLECTION XLPE 0 Degree Liner - Non-constrained polyethylene acetabular liner
Single Device Product
43168 Non-constrained polyethylene acetabular liner
The sterile, cross-linked polyethylene liner is 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. The 0 Degree neutral liner provides maximum range of motion and is used when the cup has
significant anteversion and abduction
Acetabular liner component of the Reflection Acetabular Cup 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.
Size A to K
Diameter (mm) Outer diameter 40 - 76mm
Diameter (mm) Inner diameter 22 - 36mm
No Specific Conditions included on Record
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