510(k) Report

Devices descending from K093552

38 later devices reach Evolution MP Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.20260—
+1K244039MedalOne Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.20250—
+1K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+1K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc.20240—
+1K182251EVOLUTION NitrX Medial-Pivot KneeMircoport Orthopedics, Inc.20194—
+1K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc.20173—
+1K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.20160—
+1K150496Total Knee Arthroplasty SystemResponsive Orthopedics, LLC2015012
+1K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+1K140735Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc.201451
+1K131679Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc20136—
+1K123692Pipeline Knee SystemPipeline Orthopedics20130—
+1K113325Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc20117—
+1K102380Evolution MP Total Knee SystemWrightmedicaltechnologyinc2011114
+1K100973Evolution Unicondylar Knee SystemWrightmedicaltechnologyinc20100—
+2K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+2K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+2K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+2K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc.20220—
+2K201084Physica systemLima Corporate S.P.A.20205—
+2K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+2K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+2K180317EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION®…Microport Orthopedics, Inc.20180—
+2K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+2K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+3K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+3K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+3K213381Physica systemLima Corporate S.P.A.202101
+3K211938Physica LMC Knee SystemLimacorporate20210—
+3K210554Physica systemLima Corporate S.P.A.20212—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+4K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+4K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—