510(k) Report

Devices descending from K043083

11 later devices reach Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.20160—
+1K143366ADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc.20159—
+2K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc.20220—
+2K152298EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE…Microport Orthopedics, Inc.20158—
+3K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+3K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+3K180317EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION®…Microport Orthopedics, Inc.20180—
+3K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION…Microport Orthopedics, Inc.20177—
+4K231947EVOLUTION® Cement KeelMicroport Orthopedics, Inc.20230—
+4K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc.20173—
+5K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc.20240—