510(k) Report

Devices descending from K050438

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+3K110911Renaissance SystemMazor Robotics, Ltd.201124—
+3K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+3K101791Rosa Surgical DeviceMedtech S.A.S201012612
+3K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+4K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+4K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K251315Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System IIRemex Medical Corp.20251—
+4K242569Mixed Reality Spine NavigationBrainlab AG20250—
+4K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+4K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K243258Paradigm SystemProprio, Inc.20252—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242480FLASH EVD System (10-0002)7D Surgical ULC20240—
+4K243623SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.202411
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K243560Remex Spine Surgery Navigation InstrumentRemex Medical Corp.20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K241895Cannulated PsiFGuardSpineguard20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+4K240963Spinal SystemTeslake, Inc.20240—
+4K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+4K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+4K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+4K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+4K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+4K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+4K231976StealthStation Cranial Software, v3.1.5 (9735585)Medtronic Navigation, Inc.20231—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—
+4K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+4K230661Zeta Cranial Navigation SystemZeta Surgical20233—
+4K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+4K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+4K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K231184CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20230—
+4K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+4K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+4K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+4K213815SiJoin®T3Vgi Medical, Inc.20230—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+4K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho…Stryker Leibinger GmbH & Co KG20231—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+4K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K220905xvision Spine SystemAugmedics, Ltd.20227—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222698CUVIS-spineCurexo, Inc.20220—
+4K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+4K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+4K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+4K220104Knee+Pixee Medical20227—
+4K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+4K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+4K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+4K221028SURGIVISIO DeviceEcential Robotics20227—
+4K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—