510(k) Report

Devices descending from K153442

84 later devices reach CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252322SIros-X SystemGenesys Spine20250—
+1K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+1K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+1K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+1K221244CD Horizon™ Spinal SystemMedtronic202220—
+1K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+1K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+1K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+1K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+1K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+1K172115Navigated Instrument SystemOrthofix, Inc.20184—
+1K162921Navigated Instrument SystemOrthofix, Inc.20175—
+1K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+2K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+2K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+2K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+2K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+2K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+2K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+2K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+2K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+2K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+2K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+3K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+3K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+3K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—