510(k) Report

Devices descending from K010204

158 later devices reach Stryker Navigation System-Knee Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140689Iknee Distal Femoral Cutting GuideEvergreen Orthopedic Research Lab20140—
+1K080450Stryker Power Tool Navigator AttachmentStryker Corp.20081—
+1K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp.20060—
+1K021327Orthopilot Hto ModuleAesculap, Inc.20020—
+1K013569Orthopilot 2Aesculap, Inc.2002153—
+2K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc.20160—
+2K080547Orthopilot Next Generation, Model FS101-FS106Aesculap Implant System, Inc.200822—
+2K072899Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0Aesculap Implant Systems, Inc.20080—
+2K061362Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG2006126—
+2K050752Aesculap Orthopilot 2 Tha V 2.0Aesculap, Inc.200583—
+3K102990Brainlab KneeBrainlab AG201171
+3K090375Orthopilot Next Generation-Uka Software, Model FS210Aesculap Implant System, Inc.200921—
+3K083872Imns Medacta Navigation SystemMedacta International S.A.200914—
+3K082267Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1Smith & Nephew, Inc.20081—
+3K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+3K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.200879—
+3K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+4K220652Knee 3Brainlab AG20220—
+4K193559NextAR TKA PlatformMedacta Inernational SA202012—
+4K153396Aesculap OrthoPilot Next GenerationAesculap Implant Systems, LLC20160—
+4K141694Aesculap Orthopilot Next GenerationAesculap Implant Systems, LLC201519—
+4K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+4K100314Imns Medacta Navigation System,33.221000USMedacta International S.A.201013—
+4K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+4K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+4K090313Pigalileo TKR Base V2.3 and Cas V4.1Smith & Nephew, Inc.20090—
+4K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+5K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+5K202152NextAR TKA PlatformMedacta International S.A.202011—
+5K193307HIP7Brainlab AG20200—
+5K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+5K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+5K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+5K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+6K250477NextAR (TM) SpineMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K232140OTS HipOrtoma AB202421
+6K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+6K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+6K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+6K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+6K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+6K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+6K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+6K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+6K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+6K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+6K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+7K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K250086OTS HipOrtoma AB202511
+7K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+7K231172ApolloKneeCorin U.S.A. Limited20230—
+7K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+7K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+7K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+7K192653PerseusOrthokey Italia S.R.L.20200—
+7K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+7K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+7K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+7K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+7K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+7K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+7K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+7K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+7K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+7K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+8K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+8K261852OTS HipOrtoma AB20260—
+8K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+8K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+8K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+8K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+8K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+8K242616Lantern® HipOrthalign, Inc.20241—
+8K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+8K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+8K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+8K233017TM Plating SystemTyber Medical, LLC20231—
+8K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+8K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+8K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+8K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+8K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+8K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+8K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+8K202307Activ FuseNewclip Technics20200—
+8K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+8K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+8K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+8K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+8K172462OrthAlign Plus SystemOrthalign, Inc.20178—