510(k) Report

Devices descending from K020048

1,559 later devices reach Modification to Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+8K132361Everest Spinal SystemK2m, Inc.201334—
+8K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+8K130445Vault Alif SystemSpinal USA20139—
+8K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+8K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+8K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+8K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+8K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+8K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+8K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+8K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+8K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+8K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+8K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+8K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+9K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+9K241525ExcelsiusXR™Globus Medical, Inc.20250—
+9K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+9K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+9K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+9K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+9K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+9K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+9K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+9K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+9K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+9K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K223043The Integrity Spine Core SystemIntegrity Spine20230—
+9K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+9K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+9K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+9K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+9K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+9K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+9K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+9K221244CD Horizon™ Spinal SystemMedtronic202220—
+9K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+9K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+9K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+9K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+9K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+9K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+9K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+9K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+9K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+9K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+9K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+9K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+9K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+9K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+9K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+9K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+9K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+9K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+9K201087CORBEL SpacersGlobus Medical, Inc.202036—
+9K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053