510(k) Report

Devices descending from K042167

658 later devices reach Modification to: CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+3K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+4K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+4K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+4K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K241258Ingenix Spinal SystemIngenium Spine20240—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+4K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+4K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+4K210306GII Spinal Fixation SystemColigne AG20210—
+4K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203816DeGen Navigated InstrumentationDegen Medical20211—
+4K210472SPINEART Navigation Instrument SystemSpineart20215—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K201648Sterispine™ PSSafe Orthopaedics202011
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—