510(k) Report

Devices descending from K171389

3 later devices reach EVOLUTION Revision CCK System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc.20240—
+1K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc.20220—
+1K180317EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION®…Microport Orthopedics, Inc.20180—