510(k) Report

Devices descending from K063128

7 later devices reach Advance Spiked Porous Tibial Base through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION®…Microport Orthopedics, Inc.20172—
+1K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.20160—
+1K140735Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc.201451
+2K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+2K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc.20240—
+2K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc.20220—
+3K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—