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FDA 510(k)

LEGION Total Knee System

K-Number: K250677 · 2025-04-02

ApplicantSmith & Nephew, Inc.
Decision Date2025-04-02
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEGION Total Knee System is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2025-04-02 under approval number K250677. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEGION Total Knee System?

LEGION Total Knee System is a medical device that received FDA 510(k) clearance on 2025-04-02. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K250677.

When was LEGION Total Knee System approved by the FDA?

LEGION Total Knee System received FDA 510(k) clearance on 2025-04-02, under approval number K250677.

What company makes LEGION Total Knee System?

LEGION Total Knee System is manufactured by Smith & Nephew, Inc..

What is the FDA product code for LEGION Total Knee System?

The FDA product code for LEGION Total Knee System is JWH.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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