Journey II Unicompartmental Knee System

Journey II Unicompartmental Knee System is an FDA 510(k)-cleared medical device (K190085) manufactured by Smith & Nephew, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 10, 2019. Regulation: 8.