Summary for ARTG Entry:
Zimmer Pty Ltd - NEXGEN® COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL
COMPONENT, POROUS - Coated knee femur prosthesis
ARTG entry for
Medical Device Included Class III
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
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.
1800 West Center Street
WARSAW, INDIANA, 46580
United States Of America
1. NEXGEN® COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR) FEMORAL COMPONENT, POROUS -
Coated knee femur prosthesis
Single Device Product
33745 Coated knee femur prosthesis
A CR (cruciate ligament retaining) porous coated femoral component of the NexGen semiconstrained,
nonlinked condylar knee System for cemented or uncemented (biological fixation) use. Made from
Zimaloy® Cobalt-Chromium-Molybdenum alloy.
Intended to repair or replace the femoral knee joint 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.
Size E - H
Size A Micro - E Micro
No Specific Conditions included on Record
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