Summary for ARTG Entry:
Stryker Australia Pty Ltd - TRIATHLON POSTERIOR STABILISED (PS) 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
15 Dart Road
Newnan, GA, 30265-1017
United States Of America
1. TRIATHLON POSTERIOR STABILISED (PS) 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 PS or TS Femoral Component from the Triathlon Total Knee. A locking wire
locks the tibial insert of the Tibial Base plate and the tibial post fits with the articulating femoral component.
Tibial Insert made of polyethylene (UHMWPE), locking wire made of CoCr.
A component of a reconstructive knee system, connects with a tibial baseplate 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.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) 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.
Thickness 9mm - 25mm
Size 1 to 8
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 10.11.2017 at 07:42:20 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information