510(k) Report

Devices descending from P940002

145 later devices reach Natural-Knee (R) and Natural Knee (R)II W/Csti (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc.200712363
+1K033810Natural-Knee II Unicompartmental Knee SystemCenterpulse Orthopedics, Inc.2004201
+2K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+2K133811Restoris Porous Partial Knee SystemMako Surgical Corp.201419—
+2K131310GMK Full PE Tibial ComponentsMedacta International20132—
+2K113369Zimmer Persona Knee SystemZimmer, Inc.20129639
+2K110950Consensus Knee SystemConsensus Orthopedics, Inc.201114—
+2K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+2K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc.20081175
+2K071107Gender Solutions Natural-Knee Flex System; Nex Gen Complete Knee Solution CR-Flex Gender…Zimmer, Inc.200705
+3K262057GMK ExtensionMedacta International SA20260—
+3K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+3K242307ACHIEVE Partial Knee SystemIgnite Orthomotion20241—
+3K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+3K230078TRAX® CR Total Knee SystemAmplitude20230—
+3K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+3K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+3K212129Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH20210—
+3K210062Mectaplug PE IIMedacta International S.A.20210—
+3K200209Persona Personalized Knee SystemZimmer, Inc.20202—
+3K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+3K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+3K190439Engage™ Partial Knee SystemEngage Uni, LLC201954
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+3K191625Persona Revision Knee SystemZimmer, Inc.201911
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+3K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.20173—
+3K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+3K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162—
+3K150410Restoris Porous Partial Knee SystemMako Surgical Corporation20150—
+3K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc.20153—
+3K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+3K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc.20147—
+3K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+3K133737Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionZimmer, Inc.20145—
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+3K130143Persona Natural Tibia BaseplatesZimmer, Inc.201321—
+3K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+3K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+3K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221—
+3K122765Persona Natural Tibia BaseplatesZimmer, Inc.2012252
+3K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+3K120313Neo CR Knee SystemPipeline Orthopedics20123—
+3K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated…Tgm Medical, Inc.20111—
+4K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, 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—
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+4K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+4K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+4K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+4K213381Physica systemLima Corporate S.P.A.202101
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K201611Apex Knee SystemOmnilife Science20210—
+4K210551Persona Revision Knee SystemZimmer, Inc.202101
+4K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+4K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+4K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+4K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+4K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+4K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+4K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+4K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+4K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+4K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+4K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+4K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+4K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+4K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+4K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+4K131368Neo Knee SystemPipeline Orthopedics20131—
+4K130084Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial…Tgm Medical, Inc.20130—
+4K122500Neo PS Knee SystemPipeline Orthopedics20131—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+5K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+5K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+5K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+5K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+5K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+5K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—