Summary for ARTG Entry:
Smith & Nephew Pty Ltd - REFLECTION Constrained Liner Adaptor - 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 Constrained Liner Adaptor - Constrained polyethylene acetabular liner
Single Device Product
44362 Constrained polyethylene acetabular liner
A three-piece construct that is package-assembled on a plastic Y-shaped holder, designed to help align
the rings during impaction. It attaches to any Reflection or Reflection Interfit shell and provides the pull-out
strength necessary for constrained liner applications. The device is inserted into the shell and aligned by
hand or with a hex screwdriver. It is impacted into the shell, which loosens the center Y-shaped holder for
An implantable component and non-implantable holder intended to be used with the REFLECTION
Constrained Liner. 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 diameter 46 to 76mm
No Specific Conditions included on Record
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