Summary for ARTG Entry:
Smith & Nephew Pty Ltd Chrome Modular 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. Cobalt Chrome Modular Femoral Head - Metallic femoral head prosthesis
Single Device Product
33175 Metallic femoral head prosthesis
A sterile implantable artificial femoral head that is made of a Cobalt Chrome alloy and is designed to mate
with a titanium taper sleeve and articulate with a polyethylene acetabular prosthesis as part of a total hip
arthroplasty. Modular heads are designed to fit on any Smith & Nephew femoral stem. The taper sleeve is
firmly placed on the taper and the modular head is placed on the sleeve and impacted with a mallet.
A sterile femoral head component of a total hip system. It attaches to a sleeve placed on the trunnion of a
femoral stem prosthesis and articulates with an acetabulum prosthesis. 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) 40 and 44
No Specific Conditions included on Record
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