510(k) Report

Devices descending from K991581

348 later devices reach Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+3K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+3K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+3K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+3K231975PNK Total Knee SystemTjc Life Co., Ltd.20230—
+3K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—
+3K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+3K230555Cemented Tibia Baseplate no Taper with JRNY LockSmith & Nephew, Inc.20230—
+3K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+3K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+3K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+3K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+3K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+3K213381Physica systemLima Corporate S.P.A.202101
+3K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+3K211664GMK Sphere RevisionMedacta International S.A.20210—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+3K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+3K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+3K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K200122MOTO PFJ SystemMedacta International S.A.20202—
+3K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+3K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+3K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+3K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+3K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+3K171365Arthrex Knee SystemsArthrex, Inc.20170—
+3K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc.20174—
+3K162035GMK SphereMedacta International S.A.201710—
+3K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+3K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+3K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+3K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+3K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+3K140826GMK Sphere ExtensionMedacta International201417—
+3K131368Neo Knee SystemPipeline Orthopedics20131—
+3K123721GMK Revision ExtensionMedacta International20133—
+3K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+3K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+3K122991Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+3K122232GMK NarrowMedacta International20128—
+3K122033Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+3K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+3K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+3K113378Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+3K120068Conformis Itotal CR Knee Replacement System (KRS)Conformis, Inc.201236—
+3K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201138—
+3K110950Consensus Knee SystemConsensus Orthopedics, Inc.201114—
+3K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+3K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K103352Versafitcup CC TrioMedacta International20114—
+3K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+3K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2011401
+3K102437GMK Revision Knee SystemMedacta International S.A.201034—
+3K093746Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc.201029—
+3K093806Myknee Cutting BlocksMedacta International S.A.201016—
+3K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc.20081175
+3K072160Nexgen Trabecular Metal Tibial TrayZimmer, Inc.20071081
+3K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc.200514—
+3K041100Nexgen Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc.200463
+4K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+4K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+4K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+4K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+4K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+4K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+4K231037MyKnee UNI-STMedacta International S.A.20230—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.20211—
+4K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+4K211938Physica LMC Knee SystemLimacorporate20210—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K201084Physica systemLima Corporate S.P.A.20205—
+4K193559NextAR TKA PlatformMedacta Inernational SA202012—
+4K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+4K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+4K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—