국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
Zimmer Biomet Pty Ltd
Class III
Zimmer Inc 1800 W Center Street, WARSAW , INDIANA, 46580 United States Of America
32832 - Uncoated knee tibia prosthesis, metallic
Tibial Tray component of the NexGen? Complete Knee Solution MIS (Minimally Invasive Solutions) system used in minimally invasive total knee arthrotomy and total knee procedures utilising a larger incision. It is made from Tivanium? Ti-6Al-4V Alloy and Trabecular Metal (tantalum) material (TM) and may be used with or without bone cement (biological fixation). The NexGen? Complete Knee Solution, Zimmer? MIS Solutions Procedures, Trabecular Metal Technology, Tibial Tray, Fixed Bearing is intended to repair or replace the tibial 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.
A
2014-12-05