510(k) Report

Devices descending from K022365

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162937Stryker OrthoMap Versatile Hip SystemStryker Corporation20179—
+1K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+1K080450Stryker Power Tool Navigator AttachmentStryker Corp.20081—
+1K072271Stryker Navigation System Infinitus Hip Resurfacing ModuleStryker Corp.20070—
+1K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+1K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp.20060—
+1K050615Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000Stryker Instruments200529—
+2K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho…Stryker Leibinger GmbH & Co KG20231—
+2K213380360CASKico Knee Innovation Company Pty Limited20222—
+2K203751OMNIVision systemCorin USA20210—
+2K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+2K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+2K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc.20160—
+2K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+2K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+2K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+2K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.200879—
+3K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+3K223927360CASKico Knee Innovation Company Pty Limited20231—
+3K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+3K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+3K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+3K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+3K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+4K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+4K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+4K252847NextAR Hip PlatformMedacta International S.A.20260—
+4K242616Lantern® HipOrthalign, Inc.20241—
+4K242009360CAS KneeKico Knee Innovation Company Pty, Ltd.20240—
+4K223351Naviswiss KneeNaviswiss AG20230—
+4K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+4K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+4K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+4K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+5K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+5K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+5K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+5K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+5K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+5K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+5K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+5K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+5K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+5K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+5K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+6K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+6K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+6K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+6K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+6K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+6K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+6K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+6K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+6K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+6K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+6K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+6K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+6K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+6K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+6K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+6K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+7K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+7K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+7K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+7K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+7K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+7K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+7K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+7K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+7K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+7K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+7K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+7K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+7K202307Activ FuseNewclip Technics20200—
+7K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+7K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+7K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+7K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+7K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+7K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+8K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+8K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+8K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+8K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+8K172886Breakaway Screw SystemParagon 2820174—
+8K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+8K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+8K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+9K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+9K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+9K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+9K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+9K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+9K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—