510(k) Report

Devices descending from K141494

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+1K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+1K161627PASS LP Spinal SystemMedicrea International SA20167—
+1K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+1K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+1K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+2K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+2K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+2K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+2K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+2K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+2K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+2K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+2K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+2K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+2K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+2K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+2K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+2K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+2K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+2K162786PASS LP Spinal SystemMedicrea International SA20176—
+2K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+2K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+2K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+2K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K202771CD Horizon Spinal SystemMedtronic202021—
+3K200070ARx Spinal SystemLife Spine, Inc.20209—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+3K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+3K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—