510(k) Report

Devices descending from K113174

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+2K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+2K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+2K172115Navigated Instrument SystemOrthofix, Inc.20184—
+2K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+2K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+2K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+2K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+2K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+2K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+2K162921Navigated Instrument SystemOrthofix, Inc.20175—
+2K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+2K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+2K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+2K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+2K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+2K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K151974Polaris Spinal SystemBiomet Spine201516—
+2K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+2K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+2K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+2K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+2K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+2K142360Everest Spinal SystemK2m, Inc.201522—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+2K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+2K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+2K140529Everest Spinal SystemK2m, LLC201431—
+2K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+2K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+2K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+2K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K132757Everest Spinal SystemK2m, Inc.201341—
+2K132303Implanet Spine SystemImplanet, S.A.201315—
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+2K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+3K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+3K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+3K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+3K252437JAZZ Spinal SystemImplanet20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K240392JAZZ Spinal SystemImplanet20241—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K231479TriALTIS Spine SystemMedos International SARL20238—
+3K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—