Summary for ARTG Entry:
Stryker Australia Pty Ltd - DURACON UNIVERSAL TIBIAL BASEPLATE, NON BEADED - Uncoated knee
tibia prosthesis, metallic
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 UNIVERSAL TIBIAL BASEPLATE, NON BEADED - Uncoated knee tibia prosthesis, metallic
Single Device Product
32832 Uncoated knee tibia prosthesis, metallic
A sterile implantable Tibial Tray/ Baseplate, designed to connect with a Tibial Insert that articulates with an
artificial Femoral Component of the Duracon Total Knee Arthroplasty (TKA) System. Keel Designed with
wide posteriorly angled fins, with the option for an extension stem to be attached, when required. Intended
for use with cement. Made of Cast Vitallium Alloy.
A component of a reconstructive knee system that connects with a tibial insert that 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.
Length (mm) A/P 39mm - 60mm
Length (mm) M/L 64mm - 85mm
No Specific Conditions included on Record
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