510(k) Report

Devices descending from K833921

149 later devices reach Agc Total Knee Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K094013HLS Kneetec SystemTornier20111—
+1K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460—
+1K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc.200386—
+1K984054Agc V2 Revision Knee SystemBiomet, Inc.19992—
+1K961021Kirschner Knee ModifiedBiomet, Inc.19977—
+2K210554Physica systemLima Corporate S.P.A.20212—
+2K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+2K142933Biomet Tibial traysBiomet, Inc.201463
+2K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+2K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+2K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier20120—
+2K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+2K100900Motivation Knee SystemEncore Medical L.P.2010724
+2K090411Freedom Metal Backed Tibial ComponentMaxx Orthopedics, Inc.200915—
+2K080361Regenerex Tibial ComponentsBiomet, Inc.2008131
+2K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.20060—
+2K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp200647—
+2K041872Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral PegsBiomet Manufacturing Corp20040—
+3K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+3K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.20260—
+3K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+3K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+3K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+3K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc.20251—
+3K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+3K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+3K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+3K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+3K201084Physica systemLima Corporate S.P.A.20205—
+3K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.20202—
+3K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+3K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+3K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.201821
+3K161414Anatomic Total Knee SystemAmplitude20171—
+3K160771Destiknee Total Knee SystemMeril Healthcare Private Limited20163—
+3K160342EMPOWR PS Knee SystemEncore Medical L.P.201665
+3K153657Vanguard XP Knee SystemBiomet, Inc.201611
+3K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+3K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+3K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+3K143635KINETIS Total Knee SystemMako Surgical20150—
+3K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+3K140830Exprt Revision KneeEncore Medical L.P.201471
+3K140257Signature Planner, Signature GuidesMaterialise NV20140—
+3K131481Freedom PCK ComponentsMaxx Orthopedics, Inc.20146—
+3K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+3K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+3K122239Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Encore Medical L.P.201320—
+3K121727Movation Knee SystemEncore Medical L.P.201214—
+3K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+3K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+3K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+4K262057GMK ExtensionMedacta International SA20260—
+4K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+4K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+4K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+4K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+4K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+4K253144Freedom® Total Knee System – Titan PCK ComponentsMaxx Orthopedics, Inc.20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+4K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+4K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+4K240863Freedom® Total Knee SystemMaxx Orthopedics, Inc.20240—
+4K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+4K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+4K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+4K230078TRAX® CR Total Knee SystemAmplitude20230—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+4K213381Physica systemLima Corporate S.P.A.202101
+4K212839Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20211—
+4K211938Physica LMC Knee SystemLimacorporate20210—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K191625Persona Revision Knee SystemZimmer, Inc.201911
+4K182872LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG20198—
+4K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+4K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+4K172936Destiknee™ Total Knee SystemMeril Healthcare Pvt., Ltd.20172—
+4K171991EMPOWR Porous Knee SystemEncore Medical L.P.201713
+4K170573Empowr CR Knee Tibial InsertEncore Medical L.P.20170—
+4K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+4K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+4K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Waldemar Link GmbH & Co. KG2016916
+4K150680Freedom Cementless Femoral ComponentMaxx Orthopedics, Inc.20151—
+4K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+4K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+5K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+5K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+5K222816Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd.20220—
+5K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG20220—
+5K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…Waldemar Link GmbH & Co. KG2021122