JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System

JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System is an FDA 510(k)-cleared medical device (K222653) 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 October 27, 2022. Regulation: 8.