Summary for ARTG Entry:
Smith & Nephew Pty Ltd - Echelon Porous Plus HA Standard Collar Femoral Component - Coated 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 Porous Plus HA Standard Collar Femoral Component - Coated femoral stem prosthesis, modular
Single Device Product
34191 Coated femoral stem prosthesis, modular
A Cobalt Chrome straight femoral stem with a RoughCoat porous plus hydroxyapatite coating to the
implant tip. The stem has a standard collar, a circulotrapezoidal neck providing an increased range of
motion, a threaded driving platform with an elliptical slot for rotational and axial implant control during
insertion. Following sequential reaming and broaching of the femur, the calcar is reamed and the stem
trialed. The stem is impacted into place using a threaded stem inserter and a mallet.
The ECHELON Porous Plus HA Standard Collar stem is a femoral component of a total revision hip
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.
Length (mm) Neck length 37-41mm
No Specific Conditions included on Record
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