510(k) Report

Devices descending from K051024

493 later devices reach Expedium Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—