Summary for ARTG Entry:
Stryker Australia Pty Ltd - C-TAPER ALUMINA CERAMIC HEAD - Ceramic femoral head prosthesis
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. C-TAPER ALUMINA CERAMIC HEAD - Ceramic femoral head prosthesis
Single Device Product
38156 Ceramic femoral head prosthesis
A sterile implantable ball-shaped component used to replace the anatomical Femoral Head. Intended to fit
on the trunnion of a Femoral Hip Stem and articulate with an artificial Acetabular Component. Made of
Alumina Ceramic. Comes in a range of sizes to suit patient anatomical requirements.
An implantable ball-shaped component used to replace the anatomical femoral head and intended to
attach to the grunion of a femoral stem component used in a total or hemi hip joint replacement.
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis,
post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head
replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or
alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of
poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the
Diameter (mm) 28mm - 36mm
Offset -2.5mm to +5mm
No Specific Conditions included on Record
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