Summary for ARTG Entry:
Stryker Australia Pty Ltd - UNIX UNICONDYLAR KNEE TIBIAL INSERTS - Unicondylar knee insert
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. UNIX UNICONDYLAR KNEE TIBIAL INSERTS - Unicondylar knee insert
Single Device Product
48070 Unicondylar knee insert
A sterile implantable Tibial Insert, designed to be connected with a Tibial Tray/ Baseplate for fixation and
articulates with an artificial Femoral Component on the corresponding condyle. A component of the Unix
unicompartmental Knee System intended to replace the bearing surface of one tibial condyle (medial or
lateral condyle) of the knee joint. made of polyethylene (UHWMPE).
A modular unicondylar knee that replaces the bearing surfaces of one femoral condyle and the
corresponding tibial condyle, to achieve reconstruction replacement of the deficient knee component.
Indication: Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic
arthritis. Revision of previous unsuccessful unicompartmental knee replacement or other procedure. As an
alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
Thickness 8mm - 15mm
No Specific Conditions included on Record
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