510(k) Report

Devices descending from K113369

96 later devices reach Zimmer Persona Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230078TRAX® CR Total Knee SystemAmplitude20230—
+1K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+1K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+1K212129Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH20210—
+1K200209Persona Personalized Knee SystemZimmer, Inc.20202—
+1K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+1K181947Persona Revision Knee SystemZimmer, Inc.201841
+1K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+1K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+1K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+1K133737Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionZimmer, Inc.20145—
+1K123692Pipeline Knee SystemPipeline Orthopedics20130—
+1K130143Persona Natural Tibia BaseplatesZimmer, Inc.201321—
+1K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+1K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221—
+1K122765Persona Natural Tibia BaseplatesZimmer, Inc.2012252
+1K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+2K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+2K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+2K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+2K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+2K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+2K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+2K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+2K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+2K213381Physica systemLima Corporate S.P.A.202101
+2K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+2K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+2K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+2K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+2K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+2K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+2K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+2K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+2K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+2K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+3K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+3K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+3K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+3K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+3K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+3K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+3K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+3K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+3K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+3K171365Arthrex Knee SystemsArthrex, Inc.20170—
+3K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+3K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+3K153586Arthrex iBalance TKA SystemArthrex, Inc.20161—
+3K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+3K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+3K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+4K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+4K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+4K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+4K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+4K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+4K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+4K211938Physica LMC Knee SystemLimacorporate20210—
+4K201084Physica systemLima Corporate S.P.A.20205—
+4K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+4K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+4K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+4K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+5K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+5K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+5K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+5K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+5K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+5K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+5K210554Physica systemLima Corporate S.P.A.20212—
+5K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+5K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+5K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+5K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+5K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+6K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+6K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+6K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+6K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+6K203421Triathlon AS-1Conformis, Inc.20210—
+6K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+9K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+10K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301