510(k) Report

Devices descending from K112473

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240392JAZZ Spinal SystemImplanet20241—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+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—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+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—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+4K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+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—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+4K183381Navigation Enabled InstrumentsStryker20191—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+4K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+4K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+4K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+4K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173126Arisstos™ Spinal SystemIngenium Spine20171—
+4K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+4K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K170647Connector SystemOrthofix, Inc.201718—
+4K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+4K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162764Jazz Frame SystemImplanet, S.A.20176—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K161842Overwatch Spine SystemAmendia, Inc.201661