đź“‹ FDA Reference
nexgen complete knee solution cross-linked polyethylene cruciate retaining cr articular surface components
Zimmer
Summary: The NexGen Complete Knee Solution is a knee replacement component used in orthopedic surgeries. It is designed for patients requiring knee arthroplasty, typically used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K003910 ↗
Decision Date
March 19, 2001
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The NexGen Complete Knee Solution was cleared via the FDA 510(k) pathway on March 19, 2001. Manufactured by Zimmer, it is classified as a Class 2 medical device under product code JWH.
What It Is
The NexGen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining Articular Surface Components are part of a knee replacement system. These components are designed to replace the articular surface of the knee joint, providing a durable and wear-resistant surface that mimics the natural movement of the knee. The cross-linked polyethylene material enhances the longevity and performance of the implant by reducing wear.
Clinical Applications
This device is commonly used in total knee arthroplasty procedures, particularly in patients with severe osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. It is typically utilized in orthopedic surgical settings, catering to adult and elderly patient populations who require knee joint replacement to restore mobility and alleviate pain. Orthopedic surgeons are the primary users of this device.
Indications for Use
The device is indicated for patients who need knee joint replacement due to conditions such as osteoarthritis, rheumatoid arthritis, or significant knee injuries. It is suitable for those who have not responded to conservative treatments and require surgical intervention to improve joint function.
Practical Considerations
The NexGen Complete Knee Solution is available in various sizes to accommodate different patient anatomies. It is crucial to ensure compatibility with other components of the knee replacement system. Surgeons should be familiar with the surgical technique specific to cruciate retaining knee implants to optimize outcomes.
Frequently Asked Questions
What is the NexGen Complete Knee Solution used for?
It is used for knee joint replacement in patients with severe arthritis or knee damage, providing a durable and functional joint surface.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement and arthroplasty procedures typically use this device.
What are the FDA-cleared indications?
The device is indicated for knee replacement in patients with osteoarthritis, rheumatoid arthritis, or significant knee injuries requiring surgical intervention.
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.