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nexgen complete knee solution lps-flex prolong highly crosslinked polyethylene articular surfaces
Zimmer
Summary: The NexGen Complete Knee Solution LPS-Flex is a knee replacement component used in orthopedic surgeries to improve joint function in patients with severe knee damage. It is primarily used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K042271 ↗
Decision Date
October 13, 2004
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on October 13, 2004. Manufactured by Zimmer, it is classified as a Class 2 device under product code JWH.
What It Is
The NexGen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular Surfaces is a component of a total knee replacement system. It is designed to replace the articular surface of the knee joint, providing a durable and flexible interface that mimics natural knee movement. The highly crosslinked polyethylene material enhances wear resistance, which is crucial for the longevity of the implant.
Clinical Applications
This device is commonly used in total knee arthroplasty procedures, particularly for patients with osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. It is typically utilized in orthopedic surgical settings, including hospitals and specialized orthopedic clinics. The primary patient population includes adults with significant knee joint degeneration who require surgical intervention to restore mobility and reduce pain.
Indications for Use
The FDA indications suggest that this device is intended for patients who need knee joint replacement due to severe arthritis or joint damage. It is suitable for individuals who have not responded adequately 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 compatible with other components of the NexGen Knee System, allowing for a customized fit. Surgeons should be familiar with the specific surgical techniques required for implanting this device to ensure optimal outcomes.
Frequently Asked Questions
What is the NexGen Complete Knee Solution used for?
It is used for total knee replacement surgeries to improve joint function and reduce pain in patients with severe knee damage.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement surgeries typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing knee joint replacement due to severe arthritis or joint damage, particularly when conservative treatments have failed.
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.