Summary for ARTG Entry:
Stryker Australia Pty Ltd - Triathlon All Poly Tibial Component PS - Uncoated knee tibia 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. Triathlon All Poly Tibial Component PS - Uncoated knee tibia prosthesis, polyethylene
Single Device Product
33580 Uncoated knee tibia prosthesis, polyethylene
A sterile implantable all polyethylene tibial component, designed to be cemented into the tibia and to
articulate with an artificial femoral component for a Total Knee Arthroplasty (TKA).
A tibial component of the Triathlon Total Knee used to replace the tibial plateau of the knee joint. General
Total Knee Arthroplasty (TKR) Indications: Painful, disabling joint disease of the knee resulting from:
non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular
necrosis), rheumatoid arthritis or post-traumatic arthritis. Post-traumatic loss of knee joint configuration and
function. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned
to adequate function and stability. Revision of previous unsuccessful knee replacement or other
procedure. Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture
management techniques. Additional Indications for Posterior Stabilized (PS) Components: Ligamentous
instability requiring implant bearing surface geometries with increased constraint. Absent or
non-functioning Posterior Cruciate Ligament. Severe anteroposterior instability of the knee joint.
Length (mm) A/P 40mm - 60mm
Length (mm) Keel 20mm - 28mm
Width (mm) Keel 42mm - 53mm
Size 1 - 8
Length (mm) M/L 61mm - 85
Thickness 9mm - 16mm
No Specific Conditions included on Record
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