510(k) Report

Devices descending from K050438

944 later devices reach Stealthstation System Update through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+5K250879Paradigm SystemProprio, Inc.20251—
+5K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+5K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+5K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K241327Navient Image Guide Navigation System (955-NC-NC), CranialClaronav20250—
+5K243657ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc.20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K241481xvision Spine SystemAugmedics, Ltd.20243—
+5K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+5K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+5K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233903Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.20242—
+5K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+5K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+5K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+5K232176STELLAR KneePolarisar, Inc.20230—
+5K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+5K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+5K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+5K230045HipCheckStryker Corp.20230—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K231284OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc.20231—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+5K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+5K231886SURGIVISIO DeviceEcential Robotics20236—
+5K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+5K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+5K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+5K230789Knee+Pixee Medical20235—
+5K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+5K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K223032SIS System (Version 5.6.0)Surgical Information Sciences, Inc.20223—
+5K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+5K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+5K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+5K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+5K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+5K220593Spine Guidance Software, Stryker Q Guidance SystemStryker Leibinger GmbH & Co KG202210—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+5K213380360CASKico Knee Innovation Company Pty Limited20222—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+5K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+5K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+5K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+5K210306GII Spinal Fixation SystemColigne AG20210—
+5K203205Navigated Spine InstrumentsStryker Spine20218—
+5K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K201053PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20201—
+5K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+5K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+5K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+5K172444ROSA BRAIN (v3.0.0.5)Medtech S.A201814Class I
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K171677Clear Guide SCENERGYClear Guide Medical20173—
+5K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+5K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+5K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+5K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+5K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K163020Xperius Ultrasound SystemPhilips Health Care201611