510(k) Report

Devices descending from K050438

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+4K213918DeGen Navigated InstrumentationDegen Medical20220—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+4K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+4K212397StealthStation S8 Cranial v2.0Medtronic Navigation20214Class I
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+4K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+4K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+4K211596CD Horizon Spinal SystemMedtronic20213—
+4K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+4K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+4K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+4K210153NextAR RSA PlatformMedacta International S.A.202151
+4K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+4K210071SIS System (Version 5.1.0)Surgical Information Sciences, Inc.20214—
+4K210472SPINEART Navigation Instrument SystemSpineart20215—
+4K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K202749ADAPT for Gamma3Stryker GmbH20200—
+4K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+4K202152NextAR TKA PlatformMedacta International S.A.202011—
+4K203005Mazor XMazor Robotics, Ltd.2020141
+4K202771CD Horizon Spinal SystemMedtronic202021—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+4K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+4K192173ROSA ONE Spine applicationMedtech S.A20190—
+4K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+4K183325Modus NavSynaptive Medical, Inc.20190—
+4K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K183196Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers…Stryker Corporation20190—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K182359HipCheckStryker Corp.20181—
+4K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+4K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+4K173946ADAPT for Gamma3Stryker GmbH20182—
+4K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+4K180307Mazor XMazor Robotics, Ltd.201817—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+4K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+4K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock…Stryker Corporation201712—
+4K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+4K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+4K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG201616—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+4K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+4K153004Clear Guide SCENERGYClear Guide Medical20164—
+4K151359ROSA BrainMedtech S.A201520Class I
+4K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+4K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+4K143420SYMBIS Surgical SystemImris, Inc.20150—
+4K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+4K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+4K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+4K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+4K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+4K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+4K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+4K140808Q-StationPhilips Ultrasound, Inc.201402
+4K140254EZONO 4000Ezono AG201413—
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+5K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K252742Navigated InstrumentsTyber Medical, LLC20251—
+5K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+5K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—