Summary for ARTG Entry:
Smith & Nephew Pty Ltd - Spectron Revision Long Straight Femoral Component - Uncoated femoral stem
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. Spectron Revision Long Straight Femoral Component - Uncoated femoral stem prosthesis, modular
Single Device Product
34203 Uncoated femoral stem prosthesis, modular
A cemented Cobalt Chrome femoral stem with a 12/14 taper, circulotrapezoidal neck, and longitudinal
stem taper. The femoral canal is rasped with sequential broaches. After trialing and femoral canal
preparation, a Buck cement restrictor is inserted into the canal and cement is injected from a pressurized
gun. A stem driver is used to drive the stem into the femoral canal. Excess cement should be removed
prior to femoral head impaction on the neck taper.
A sterile femoral component of a total hip system. The stem was designed for revision of femoral distal
defects such as holes, windows, or fractures around the end of the previously implanted stem.
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) 165-225
Size Small Medium and Large
No Specific Conditions included on Record
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