Summary for ARTG Entry:
Stryker Australia Pty Ltd - TRIATHLON TOTAL STABILISER (TS) PLUS X3 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 TOTAL STABILISER (TS) PLUS X3 TIBIAL INSERT - Prosthesis, knee, internal, insert
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 the Triathlon Total Knee Arthroplasty (TKA). The post
on the Tibial Insert fits within the articulating femoral component. Made of X3 polyethylene (highly
A component of 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.
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.
Additional Indications for Total Stabilizer (TS) Components:
· Severe instability of the knee secondary to compromised collateral ligament integrity or function.
Size 1 to 8
Thickness 9mm to 31mm
No Specific Conditions included on Record
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