510(k) Report

Devices descending from K023211

293 later devices reach Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K262057GMK ExtensionMedacta International SA20260—
+4K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.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—
+4K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+4K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+4K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+4K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+4K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+4K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+4K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+4K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.20211—
+4K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+4K211664GMK Sphere RevisionMedacta International S.A.20210—
+4K211938Physica LMC Knee SystemLimacorporate20210—
+4K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+4K210062Mectaplug PE IIMedacta International S.A.20210—
+4K210554Physica systemLima Corporate S.P.A.20212—
+4K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+4K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC202041
+4K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+4K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+4K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+4K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+4K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+4K171365Arthrex Knee SystemsArthrex, Inc.20170—
+4K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+4K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.20173—
+4K162035GMK SphereMedacta International S.A.201710—
+4K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162—
+4K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+4K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+4K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+4K153586Arthrex iBalance TKA SystemArthrex, Inc.20161—
+4K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+4K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+4K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+4K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+4K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+4K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+4K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc.20153—
+4K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+4K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics20142811
+4K140826GMK Sphere ExtensionMedacta International201417—
+4K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc.20147—
+4K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics2013381
+4K123721GMK Revision ExtensionMedacta International20133—
+4K122232GMK NarrowMedacta International20128—
+4K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated…Tgm Medical, Inc.20111—
+4K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+4K103721Mpact Acetabular SystemMedacta International201121—
+4K103352Versafitcup CC TrioMedacta International20114—
+4K102437GMK Revision Knee SystemMedacta International S.A.201034—
+4K093806Myknee Cutting BlocksMedacta International S.A.201016—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+5K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+5K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K241461Mpact Constrained LinerMedacta International S.A.20251—
+5K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+5K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250—
+5K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+5K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+5K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+5K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+5K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+5K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+5K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+5K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+5K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC20240—
+5K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+5K230011Mpact ExtensionMedacta International S.A.20233—
+5K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+5K231037MyKnee UNI-STMedacta International S.A.20230—
+5K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+5K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+5K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K220049Optimotion Implants Porous Metal-Backed PatellaOptimotion Implants, LLC20220—
+5K212941Porous PatellaEncore Medical, L.P. Dba Djo Surgical202211