📋 FDA Reference
Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining Cr Articular Surface Components
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a component of a total knee replacement system in patients requiring knee arthroplasty.
- Use as a cruciate-retaining articular surface component with compatible NexGen knee replacement components.
- Use to replace the articular bearing surface of the knee joint when surgical knee replacement is indicated.
Clinical Applications
- Cruciate-retaining total knee arthroplasty.
- Replacement of the tibial polyethylene bearing surface in a compatible knee replacement system.
- Treatment of knee joint disease or damage for which total knee replacement is indicated, as determined by the treating orthopedic surgeon.
- Use with other compatible components of the NexGen Complete Knee Solution system.
Practical Considerations
- The insert must be matched to the compatible femoral and tibial components, implant design, size, and surgical technique.
- The device is available in multiple sizes; selection depends on the patient's anatomy and the implanted knee system.
- Cruciate-retaining designs are intended for cases in which the posterior cruciate ligament and overall knee stability are appropriate for this implant configuration.
- Implantation requires orthopedic surgery with sterile handling, bone preparation, and appropriate anesthesia or sedation.
- MRI safety and conditions depend on the complete implanted knee system and its current labeling; patients should provide the exact implant information before MRI.
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.