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nexgen knee prosthesis legacy knee prosthesis w co-nidium surface hardening process
Zimmer
Summary: The NexGen Knee Prosthesis by Zimmer is a knee replacement device used primarily for total knee arthroplasty. Key evidence highlights its long-term efficacy and safety in improving knee function.
FDA Clearance Information
Pathway
510K
Number
K962196 ↗
Decision Date
August 23, 1996
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The NexGen Knee Prosthesis was cleared by the FDA through the 510(k) pathway on August 23, 1996. It is manufactured by Zimmer and classified as a Class 2 medical device.
What It Is
The NexGen Knee Prosthesis is a knee replacement device designed to replace the knee joint in patients with severe knee damage. It utilizes a posterior-stabilized design to improve joint stability and function.
Clinical Applications
This device is commonly used in total knee arthroplasty procedures for patients with osteoarthritis or other degenerative joint diseases. It is particularly indicated for cases requiring improved knee stability and function.
Evidence Summary
The available literature includes 15 studies, comprising prospective and retrospective analyses, with data collected from 1997 to 2019. These studies evaluate clinical, functional, and radiological outcomes of the NexGen Knee Prosthesis.
Reported Outcomes
Published studies report significant improvements in knee function and stability with the NexGen Knee Prosthesis. Outcomes such as the Knee Society Knee Score and Knee Society Function Score showed marked improvement postoperatively. Long-term survivorship and functional outcomes have been positively noted in various cohorts.
Safety Profile
Reported complications include minimal revision surgeries, indicating a favorable safety profile. The studies reviewed did not highlight significant adverse events, suggesting the device's reliability in clinical use.
Evidence Limitations
The evidence is limited by the lack of randomized controlled trials and the potential for selection bias in retrospective studies. Further research is needed to explore long-term outcomes beyond the 10-year follow-up period.
Frequently Asked Questions
What are the clinical indications for NexGen Knee Prosthesis?
The NexGen Knee Prosthesis is indicated for total knee arthroplasty in patients with osteoarthritis or other degenerative joint diseases requiring improved knee stability and function.
What outcomes have been reported in clinical studies?
Clinical studies have reported significant improvements in knee function and stability, with enhanced Knee Society Knee Scores and Function Scores postoperatively.
What complications have been reported?
Reported complications include minimal revision surgeries, with no significant adverse events highlighted in the reviewed studies.
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.