510(k) Report

Devices descending from K933785

328 later devices reach Next Generation Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K103352Versafitcup CC TrioMedacta International20114—
+4K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+4K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc.20081175
+5K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.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—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics202501
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K251737NextAR (TM) Shoulder PlatformMedacta 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—
+5K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+5K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+5K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+5K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+5K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+5K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+5K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+5K230011Mpact ExtensionMedacta International S.A.20233—
+5K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.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
+5K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+5K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+5K220049Optimotion Implants Porous Metal-Backed PatellaOptimotion Implants, LLC20220—
+5K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+5K212941Porous PatellaEncore Medical, L.P. Dba Djo Surgical202211
+5K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+5K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+5K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K200391MPACT ExtensionMedacta International S.A.20210—
+5K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+5K202152NextAR TKA PlatformMedacta International S.A.202011—
+5K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+5K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+5K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+5K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+5K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+5K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+5K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+5K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+5K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.20173—
+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—
+5K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+5K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+5K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+5K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+5K143453Mpact Double Mobility SystemMedacta International20151—
+5K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+5K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc.20147—
+5K132879Mpact ExtensionMedacta International201411—
+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—
+5K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated…Tgm Medical, Inc.20111—
+5K111145Endo HeadMedacta International20110—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+6K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+6K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+6K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+6K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+6K250477NextAR (TM) SpineMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+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—
+6K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K211891DM Converter - TiN coatedMedacta International S.A.20220—
+6K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+6K201611Apex Knee SystemOmnilife Science20210—
+6K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—