510(k) Report

Devices descending from K894334

9 later devices reach Second Generation Knee 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—
+1K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.20160—
+1K122218Advance Total Knee System-PatellaWrightmedicaltechnologyinc20132—
+1K113325Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc20117—
+2K140735Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc.201451
+2K131679Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc20136—
+3K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+3K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc.20220—
+4K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—