Genesis II XLPE Resurfacing Patellar Components

Genesis II XLPE Resurfacing Patellar Components is an FDA 510(k)-cleared medical device (K150241) 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 26, 2015. Regulation: 8.