510(k) Report

Devices descending from K993239

82 later devices reach Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080450Stryker Power Tool Navigator AttachmentStryker Corp.20081—
+1K062640Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments20065019
+1K050615Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000Stryker Instruments200529—
+2K203751OMNIVision systemCorin USA20210—
+2K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+2K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc.20160—
+2K142024Brightmatter Navigation SystemSynaptive Medical, Inc.2015121
+2K141551Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees)…Stryker Corporate2014201
+2K131214Cranial Map NeuroStryker Corporate201326—
+2K093206Orthomap 3D 1.1 ModuleStryker Corp.20100—
+2K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+2K083009Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000Stryker Leibinger GmbH & Co KG20091—
+3K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+3K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+3K1810417D Surgical System Cranial Application7D Surgical, Inc.20186—
+3K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+3K162929Stryker Navigation System with CranialMap software application, Stryker CranialMap…Stryker Corporation20173—
+3K153240Styrker OrthoMap Express Knee SystemStryker Corporate201617—
+3K151156Fiagon Navigation SystemFiagon GmbH20161—
+3K153281BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc.20162Class I
+3K141941Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D…Stryker Corporate201422—
+3K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+3K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+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—
+4K242616Lantern® HipOrthalign, Inc.20241—
+4K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+4K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation202312
+4K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho…Stryker Leibinger GmbH & Co KG20231—
+4K221028SURGIVISIO DeviceEcential Robotics20227—
+4K202749ADAPT for Gamma3Stryker GmbH20200—
+4K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+4K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc.20195—
+4K183325Modus NavSynaptive Medical, Inc.20190—
+4K183196Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers…Stryker Corporation20190—
+4K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+4K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…Stryker Corporation201712—
+4K163209Fiagon Navigation SystemFiagon GmbH20170—
+4K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG201616—
+4K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+5K242480FLASH EVD System (10-0002)7D Surgical ULC20240—
+5K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+5K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+5K230661Zeta Cranial Navigation SystemZeta Surgical20233—
+5K231886SURGIVISIO DeviceEcential Robotics20236—
+5K220593Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG202210—
+5K213380360CASKico Knee Innovation Company Pty Limited20222—
+5K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+5K203205Navigated Spine InstrumentsStryker Spine20218—
+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—
+5K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+6K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+6K260546Q Pedicle InstrumentsK2m, Inc.20260—
+6K252873Q Interbody InstrumentsK2m, Inc.20260—
+6K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+6K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+6K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+6K233903Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.20242—
+6K223927360CASKico Knee Innovation Company Pty Limited20231—
+6K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+6K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+7K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+7K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+7K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+7K242351Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.20241—
+7K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+7K242009360CAS KneeKico Knee Innovation Company Pty, Ltd.20240—
+7K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+7K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+8K253663Zeta Navigation SystemZeta Surgical, Inc.20260—
+8K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+8K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+9K252847NextAR Hip PlatformMedacta International S.A.20260—