Summary for ARTG Entry:
Stryker Australia Pty Ltd - TRIATHLON X3 CRUCIATE RETAINING (CR) TIBIAL INSERT - Prosthesis,
knee, internal, insert component
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 X3 CRUCIATE RETAINING (CR) TIBIAL INSERT - Prosthesis, knee, internal, insert component
Single Device Product
46585 Prosthesis, knee, internal, insert component
A sterile implantable Tibial Insert, designed to be connected with a Tibial Tray/ Baseplate for fixation and
to articulate with an artificial Femoral Component of a Total Knee Arthroplasty (TKA). Designed to be
implanted with retention of the Posterior Cruciate Ligament. It is a component of the Triathlon Knee
System which typically includes Femoral, Tibial, and Patellar components that articulate. Made of X3
polyethylene (highly cross-linked UHWMPE).
A component of a reconstructive knee system, connects with a tibial base plate and articulates with a
femoral knee component. 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
· 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 management techniques.
Thickness 9mm - 19mm
Size 1 to 8
No Specific Conditions included on Record
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