510(k) Report

Devices descending from K102555

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+3K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+3K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+3K142360Everest Spinal SystemK2m, Inc.201522—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+3K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K132303Implanet Spine SystemImplanet, S.A.201315—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231479TriALTIS Spine SystemMedos International SARL20238—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+4K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+4K213918DeGen Navigated InstrumentationDegen Medical20220—
+4K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+4K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+4K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—