510(k) K250677

LEGION Total Knee System by Smith & Nephew, Inc. — Product Code JWH

K250677 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "LEGION Total Knee System". The FDA issued a decision of Substantially Equivalent on April 2, 2025. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.