510(k) Report

Devices descending from K112405

296 later devices reach Clydesdales Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K201793EDEN Peek CageJmt Co., Ltd.20210—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+5K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+5K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+5K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K241895Cannulated PsiFGuardSpineguard20240—
+5K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+5K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+5K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+5K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+5K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+5K213815SiJoin®T3Vgi Medical, Inc.20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+5K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+5K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+5K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+5K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+5K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K181829Velofix TLIF CageU&I Corporation20181—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—