Summary for ARTG Entry:
Zimmer Pty Ltd - PERSONA, The Personalized Knee System, Natural Tibia, Trabecular Metal, Two-Peg,
Porous, Fixed Bearing - Coated knee tibia 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. PERSONA, The Personalized Knee System, Natural Tibia, Trabecular Metal, Two-Peg, Porous, Fixed
Bearing - Coated knee tibia prosthesis
Single Device Product
34198 Coated knee tibia prosthesis
Porous tibial components of the Persona, The Personalized Knee System, semiconstrained total knee
prosthesis designed to replace the proximal portion of the tibia. Tibial components are made from
Tivanium Ti-6AI-4V alloy and Trabecular Metal material. The asymmetric tibial component is available in
left and right configurations with multiple Medial/Lateral sizes.
This device is 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
± 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.
Porous coated components may be used cemented or uncemented (biological fixation).
Shape Left & Right
Size A - J
No Specific Conditions included on Record
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