Summary for ARTG Entry:
Smith & Nephew Pty Ltd Chrome Femoral Head 12/14 Taper - 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 Femoral Head 12/14 Taper - 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. It is designed to mate
with a hip stem through a corresponding 12/14 taper and to articulate with a polyethylene acetabular
prosthesis as part of a total hip arthroplasty. Following a trial reduction with a femoral head trial, the neck
taper of the stem is wiped clean with a sterile cloth and the femoral head is placed onto the neck taper and
firmly impacted with a mallet.
A sterile femoral head component of a total hip system. It attaches to 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
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) 22 to 36
Length (mm) Neck length -3 +0 +4 +8 +12 and
No Specific Conditions included on Record
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