Summary for ARTG Entry:
Stryker Australia Pty Ltd - DURACON TOTAL STABLIZER (TS) CONSTRAINED 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. Prosthesis, knee, internal, insert component
Single Device Product
46585 Prosthesis, knee, internal, insert component
Sterile Tibial Insert designed to connect with tibial tray for fixation and articulate with Femoral Component
for a Total Knee Arthroplasty. Constrained intercondylar insert indicated in revisions where loss of one or
both collateral ligaments or inability to balance collateral ligaments in flexion & extension. With a highly
conforming tibiofemoral articulation. Tall tibial spine reinforced with preassembled Vitallium Alloy support
post to resist varus/valgus forces Made of Polyethylene (UHMWPE)
A component of reconstructive knee system, connects with a tibial base plate and articulates with a
femoral knee component. Indications for use of total knee replacement prostheses include:
1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular
2) rheumatoid arthritis;
3) correction of functional deformity;
4) revision procedures where other treatments or devices have failed;
5) post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or
prior patellectomy; and,
6) irreparable fracture of the knee.
Size Ex Large
Thickness 11mm to 31mm
No Specific Conditions included on Record
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