đź“‹ FDA Reference
nexgen complete knee solution legacy posterior stabilized lps lps-flex fixed bearing femoral and articular surface co
Zimmer
Summary: The NexGen Complete Knee Solution is a knee replacement system used in orthopedic surgery to replace damaged knee joints. It is primarily used by orthopedic surgeons for patients with severe knee arthritis or injury.
FDA Clearance Information
Pathway
510K
Number
K991581 ↗
Decision Date
July 30, 1999
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The NexGen Complete Knee Solution by Zimmer was cleared through the FDA 510k pathway on July 30, 1999. It is a Class 2 medical device under product code JWH.
What It Is
The NexGen Complete Knee Solution is a knee prosthesis designed to replace the femoral and articular surfaces of the knee joint. It features a posterior stabilized design, which provides stability by substituting for the function of the posterior cruciate ligament. This system is typically used in total knee arthroplasty procedures to restore function and relieve pain in patients with knee joint degeneration.
Clinical Applications
This device is commonly used in total knee replacement surgeries, particularly for patients suffering from osteoarthritis, rheumatoid arthritis, or traumatic knee injuries. Orthopedic surgeons utilize this system in hospital operating rooms or specialized surgical centers. It is suitable for adult patients who have not responded to conservative treatments and require surgical intervention to improve mobility and quality of life.
Indications for Use
The FDA indications for this device include use in patients who need knee joint replacement due to severe arthritis or significant knee damage. It is intended for individuals who experience pain and functional limitations that significantly impact daily activities.
Practical Considerations
The NexGen system offers various sizing options to accommodate different patient anatomies, ensuring a proper fit and alignment. Surgeons should be familiar with the surgical technique and instrumentation specific to this system to optimize outcomes and minimize complications.
Frequently Asked Questions
What is the NexGen Complete Knee Solution used for?
It is used for total knee replacement surgeries to relieve pain and restore function in patients with severe knee joint 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 requiring knee joint replacement due to severe arthritis or significant knee damage.
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.