510(k) Report

Devices descending from K002356

143 later devices reach Natural-Knee II Patellofemoral Joint Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc.20071225
+1K053488Conformis Bicompartmental Knee Repair SystemConformis, Inc.200635—
+2K200122MOTO PFJ SystemMedacta International S.A.20202—
+2K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+2K093513Iduo Bicompartmental Knee Repair SystemConformis, Inc.2009173
+2K080936Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 MM ThicknessConformis, Inc.20080—
+2K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc.20081175
+2K072586Conformis Uni-Condylar Knee SystemConformis, Inc.200730—
+2K072368Conformis Metal Backed Tibial ComponentConformis, Inc.2007313
+2K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc.2007323
+3K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+3K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.20211—
+3K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+3K191625Persona Revision Knee SystemZimmer, Inc.201911
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+3K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201227—
+3K120313Neo CR Knee SystemPipeline Orthopedics20123—
+3K113369Zimmer Persona Knee SystemZimmer, Inc.20129639
+3K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201128—
+3K110950Consensus Knee SystemConsensus Orthopedics, Inc.201114—
+3K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+3K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc.200929—
+4K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+4K230078TRAX® CR Total Knee SystemAmplitude20230—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K212129Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH20210—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K210551Persona Revision Knee SystemZimmer, Inc.202101
+4K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+4K200209Persona Personalized Knee SystemZimmer, Inc.20202—
+4K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+4K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.20173—
+4K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162—
+4K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc.20153—
+4K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+4K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+4K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc.20147—
+4K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+4K133737Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionZimmer, Inc.20145—
+4K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc.2013253
+4K131368Neo Knee SystemPipeline Orthopedics20131—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K122500Neo PS Knee SystemPipeline Orthopedics20131—
+4K130143Persona Natural Tibia BaseplatesZimmer, Inc.201321—
+4K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+4K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+4K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221—
+4K122765Persona Natural Tibia BaseplatesZimmer, Inc.2012252
+4K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+4K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated…Tgm Medical, Inc.20111—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+5K213381Physica systemLima Corporate S.P.A.202101
+5K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+5K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+5K203421Triathlon AS-1Conformis, Inc.20210—
+5K201611Apex Knee SystemOmnilife Science20210—
+5K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+5K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+5K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+5K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+5K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+5K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+5K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+5K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+5K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+5K130084Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial…Tgm Medical, Inc.20130—
+6K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+6K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+6K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+6K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+6K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+6K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+6K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+6K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+6K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+6K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—