Summary for ARTG Entry:
Zimmer Pty Ltd - Prosthesis, knee, internal, insert component
ARTG entry for
Medical Device Included (Export Only) Class 1
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
ARTG Start Date
Medical Device Class 1
- 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.
1800 West Center Street
WARSAW, INDIANA, 46580
United States Of America
1. Prosthesis, knee, internal, insert component
Single Device Product
46585 Prosthesis, knee, internal, insert component
Indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis,
traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle,
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or
prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical
attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 07:21:25 AEDT
This is not an ARTG Certificate document.
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