Summary for ARTG Entry:
Smith & Nephew Pty Ltd - Stainless Steel 12/14 Taper Femoral Head - Metallic femoral head prosthesis
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. Stainless Steel 12/14 Taper Femoral Head - Metallic femoral head prosthesis
Single Device Product
33175 Metallic femoral head prosthesis
A sterile implantable stainless steel femoral head offered in various sizes with built-in neck offset
adjustments to better match patient needs. It is designed to mate with a stainless steel femoral stem
through a corresponding 12/14 taper. The device is designed to articulate with a polyethylene liner and is
impacted onto the femoral stem with a mallet.
A stainless steel femoral head component of a total hip system, for use only with a stainless steel femoral
stem with a corresponding 12/14 taper. 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 (mm) 22mm 26mm 28mm and 32mm
Offset +0 -3 +4 +8 +12 +16
No Specific Conditions included on Record
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