Summary for ARTG Entry:
Stryker Australia Pty Ltd - DURACON CONDYLAR STABILIZING (CS) LIPPED 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. DURACON CONDYLAR STABILIZING (CS) LIPPED 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 a Total Knee Arthroplasty (TKA). Designed with an
anterior constraint which allows the Posterior Cruciate Ligament to be retained or sacrificed. It is a
component of the Duracon Knee System which typically includes Femoral, Tibial, and Patellar components
that articulate. Made of Polyethylene (UHWMPE).
A component of a 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) non-inflammatory 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
Size Ex Small
Thickness 9mm to 25mm
No Specific Conditions included on Record
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