510(k) K242711

JOURNEY II Unicompartmental Knee System (JOURNEY II UK) by Smith & Nephew, Inc. — Product Code HSX

K242711 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "JOURNEY II Unicompartmental Knee System (JOURNEY II UK)". The FDA issued a decision of Substantially Equivalent on October 30, 2024. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.