Summary for ARTG Entry:
Stryker Australia Pty Ltd - ACCOLADE HFx - Press-fit hip femur prosthesis, one-piece
ARTG entry for
Medical Device Included Class III
Stryker Australia Pty Ltd
PO Box 970,ARTARMON, NSW, 1570
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.
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah, New Jersey, 07430
United States Of America
1. ACCOLADE HFx - Press-fit hip femur prosthesis, one-piece
Single Device Product
55834 Press-fit hip femur prosthesis, one-piece
A sterile implantable one piece Femoral Hip Stem designed to replace the proximal femoral neck as part of
a Hip Arthroplasty (Available 127 Degree Neck Angle). A circumferential titanium plasma spray surface
over the proximal body assists with mechanical engagement in bone. Intraoperatively assembled with a
Femoral Head. Made of Cobalt Chrome and intended for use without cement.
A component of a total hip joint prosthesis that is used to replace the femoral neck. The indications for use
for total hip and hemi hip arthroplasty include:
1. non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head
involvement that are unmanageable using other techniques.
Offset 38mm - 54mm
Length (mm) Stem 110mm - 145mm
Length (mm) Neck 30mm - 40mm
Size 1 - 8
No Specific Conditions included on Record
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