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nexgen complete knee solution ultracongruent uc-flex fixed bearing articular surface component
Zimmer
Summary: The NexGen Complete Knee Solution is an orthopedic implant used in knee replacement surgeries. It is designed for use by orthopedic surgeons to improve joint function in patients with severe knee arthritis or damage.
FDA Clearance Information
Pathway
510K
Number
K060722 ↗
Decision Date
May 26, 2006
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on May 26, 2006. Manufactured by Zimmer, it is classified as a Class 2 medical device under product code JWH.
What It Is
The NexGen Complete Knee Solution Ultracongruent UC-Flex Fixed Bearing Articular Surface Component is a knee implant used in total knee arthroplasty. It is designed to replace the articular surface of the knee joint, providing stability and improved range of motion. The ultracongruent design offers enhanced contact area and stability, making it suitable for patients with severe knee damage.
Clinical Applications
This device is commonly used in total knee replacement surgeries, particularly for patients with osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. It is typically utilized in orthopedic surgery settings, catering to adult and elderly patient populations who require knee joint replacement to restore mobility and alleviate pain.
Indications for Use
The FDA-cleared indications include use in patients with severe knee arthritis or joint damage that necessitates knee replacement. It is intended for individuals who have not responded to conservative treatments and require surgical intervention to restore knee function.
Practical Considerations
The NexGen Complete Knee Solution comes in various sizes to accommodate different patient anatomies. It is compatible with other components of the NexGen knee system. Surgeons should be familiar with the specific surgical techniques required for implantation to ensure optimal outcomes.
Frequently Asked Questions
What is the NexGen Complete Knee Solution used for?
It is used for total knee replacement in patients with severe knee arthritis or damage.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement surgeries typically use this device.
What are the FDA-cleared indications?
It is indicated for patients with severe knee arthritis or joint damage requiring knee replacement.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.