510(k) Report

Devices descending from K031655

1,220 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+4K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+4K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+4K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+4K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+4K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+4K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+4K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+4K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+4K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+4K101144Modification to:Radius Spinal SystemStryker Spine201090—
+4K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+4K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+4K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+4K092631Mantis Redux Spinal SystemStryker Spine2009110—
+4K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+4K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+4K083393Xia 3 Spinal SystemStryker Spine20092921
+4K080767Conquest Spinal SystemLife Spine200821—
+4K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+4K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+5K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K243249TriALTIS™ Spine SystemMedos International SARL20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243693NEO Pedicle Screw System™Neo Medical SA20240—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K233300POWEReam 1/4 DriveStryker Instruments20231—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K233684TriALTIS™ Spine SystemMedos International SARL20234—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K231658VEOS Spinal Fixation SystemSpineway20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+5K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+5K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—