Summary for ARTG Entry:
Smith & Nephew Pty Ltd - ECHELON Cemented Bowed Standard Collar Femoral Component - Uncoated
femoral stem prosthesis, modular
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. ECHELON Cemented Bowed Standard Collar Femoral Component - Uncoated femoral stem prosthesis,
Single Device Product
34203 Uncoated femoral stem prosthesis, modular
A cemented Cobalt Chrome bowed femoral stem with trapezoidal distal cross section. The femoral neck is
resected and the canal is reamed incrementally. The femur is broached to size and the broach is seated
flush with the osteotomy level. Following reaming of the calcar and trialling, the femoral canal is prepared
and a Buck cement restrictor is inserted into the canal. Cement is injected into the canal from a
pressurized cement gun, and a stem inserter and mallet are used to seat the implant.
A sterile femoral component of a total hip system. The Echelon cemented femoral implants are designed
for revision use in cases where the bone stock is not optimal for cementless fixation. The bowed design
accommodates the natural bow of the femur.
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 12 and 14
Shape Left and Right
No Specific Conditions included on Record
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