510(k) Report

Devices descending from K060370

197 later devices reach Nexgen Knee Gender Solutions Female (GSF) Femoral Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K153586Arthrex iBalance TKA SystemArthrex, Inc.20161—
+4K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+4K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+4K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K140826GMK Sphere ExtensionMedacta International201417—
+4K133630GMK Short StemMedacta International20131—
+4K131368Neo Knee SystemPipeline Orthopedics20131—
+4K123721GMK Revision ExtensionMedacta International20133—
+4K130084Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial…Tgm Medical, Inc.20130—
+4K122232GMK NarrowMedacta International20128—
+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—
+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—
+5K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K241461Mpact Constrained LinerMedacta International S.A.20251—
+5K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+5K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+5K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+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—
+5K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+5K211938Physica LMC Knee SystemLimacorporate20210—
+5K200391MPACT ExtensionMedacta International S.A.20210—
+5K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+5K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+5K201084Physica systemLima Corporate S.P.A.20205—
+5K193559NextAR TKA PlatformMedacta Inernational SA202012—
+5K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+5K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+5K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+5K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+5K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+5K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+5K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+5K143453Mpact Double Mobility SystemMedacta International20151—
+5K132879Mpact ExtensionMedacta International201411—
+5K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K131458Mpact DM Liner ConverterMedacta International20133—
+5K122911Versafitcup CC Trio ExtensionMedacta International20121—
+5K122641Mpact ExtensionMedacta International201214—
+5K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+5K111145Endo HeadMedacta International20110—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K252847NextAR Hip PlatformMedacta International S.A.20260—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+6K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+6K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K211891DM Converter - TiN coatedMedacta International S.A.20220—
+6K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+6K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+6K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+6K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+6K210153NextAR RSA PlatformMedacta International S.A.202151
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+6K202152NextAR TKA PlatformMedacta International S.A.202011—
+6K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+6K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+6K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+6K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+7K250477NextAR (TM) SpineMedacta International S.A.20250—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+7K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+7K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+7K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+7K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+7K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+7K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+7K203421Triathlon AS-1Conformis, Inc.20210—
+7K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+8K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+8K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+8K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+9K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+9K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+9K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+10K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+11K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301