(98 days)
To reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus varus or flexion deformities.
Not Found
This document does not contain information about acceptance criteria or a study proving a device meets them. It is a Summary of Safety and Effectiveness for NexGen® Complete Knee Solution Legacy Posterior Stabilized (PS) and Constrained Condylar Knee (CCK) Femoral Components and Articular Surfaces, submitted to the FDA in 1996.
This document describes:
- The trade name and classification of the medical device (knee replacement components).
- The predicate devices to which the new device is compared.
- The intended use of the device.
- A general statement about clinical and nonclinical uses, mentioning reliance on bone cement and satisfactory results from predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets them based on the provided text.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, stylized letter "Z" inside of a circle. Below the circle is the word "zimmer" in a sans-serif font. The logo is black and white.
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Summary of Safety and Effectiveness NexGen® Complete Knee Solution Legacy Posterior Stabilized (PS) and Constrained Condylar Knee (CCK) Femoral Components and Articular Surfaces
Information is being submitted in accordance with the requirements of SMDA 1990
APR 2 6 1996
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Submitted by: .
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 -
Prepared by: .
Ruth Ann Wood Regulatory Affairs Associate -
Date: ●
January 18, 1996 -
. Trade Name:
NexGen Legacy PS (L-PS) and NexGen Legacy CCK (L-CCK) -
Classification Name: •
Knee joint femorotibial metal/polymer semiconstrained cemented prosthesis -
Predicate Devices: .
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The NexGen Legacy Posterior Stabilized Knee equals NexGen Posterior Stabilized and Insall/Burstein II Posterior Stabilized
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The NexGen Legacy Constrained Condylar Knee equals NexGen Constrained Condylar Knee, Insall/Burstein® II Modular Knee System, and Insall/Burstein® Constrained Condylar Knee
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Image /page/0/Picture/21 description: The image shows a geometric pattern. The pattern is composed of multiple triangles arranged in a hexagonal shape. The triangles are oriented in different directions, creating a complex and symmetrical design.
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Intended Use: .
To reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus varus or flexion deformities. -
Comparison to Predicate Devices: .
See attached chart. -
Clinical and Nonclinical Uses: .
Current methods of implant fixation rely on the use of bone cement. Numerous studies reported in literature indicate satisfactory results have been obtained through use of devices to which substantial equivalence is claimed.
RA10501K.RP
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.