EVOLUTION? Hinge Knee System;GUARDIAN? limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS? Limb Salvage System;EVOLUTION? MP Total Knee System; EVOLUTION? MP Total Knee System; EVOLUTION? MP Adaptive CS Insert; EVOLUTION? MP Adaptive PS Tibial Insert; EVOLUTION? MP CS/CR Porous Femur/EVOLUTION? Adaptive CS and PS Inserts; EVOLUTION? Revision CCK System; ADVANCE? Double High Insert; ADVANCE? A-CLASS? Tibial Insert; ADVANCE? Knee System; ADVANCE? Ultra-Congruent Tibial Inse

About This 510(k) Submission

K240043 is an FDA 510(k) clearance for the EVOLUTION? Hinge Knee System;GUARDIAN? limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS? Limb Salvage System;EVOLUTION? MP Total Knee System; EVOLUTION? MP Total Knee System; EVOLUTION? MP Adaptive CS Insert; EVOLUTION? MP Adaptive PS Tibial Insert; EVOLUTION? MP CS/CR Porous Femur/EVOLUTION? Adaptive CS and PS Inserts; EVOLUTION? Revision CCK System; ADVANCE? Double High Insert; ADVANCE? A-CLASS? Tibial Insert; ADVANCE? Knee System; ADVANCE? Ultra-Congruent Tibial Inse, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on April 1, 2024, 87 days after receiving the submission on January 5, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.