510(k) Report

Devices descending from K111136

304 later devices reach Expedium Spine System, Viper System, Viper 2 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+3K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+3K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+3K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+3K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141147Range Spinal SystemK2m, Inc.20141—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+4K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K242042TriALTIS™ Spine SystemMedos International SARL20241—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K133402K2M Modular HooksK2m, Inc.20140—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—