Cleared Special

LEGION Total Knee System

K250677 · Smith & Nephew, Inc. · Orthopedic
Apr 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K250677 is an FDA 510(k) clearance for the LEGION Total Knee System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on April 2, 2025, 27 days after receiving the submission on March 6, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number K250677 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2025
Decision Date April 02, 2025
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3560

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