510(k) Report

Devices descending from K010530

1,764 later devices reach Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+9K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+9K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+9K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+9K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+9K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+9K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+9K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+9K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+9K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+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—
+9K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+9K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+9K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+9K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+9K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+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—
+9K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+9K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+9K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+9K190284Bengal Stackable Cage SystemMedos International SARL20190—
+9K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+9K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+9K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+9K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+9K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+9K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+9K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+9K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+9K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+9K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+9K181188EVEREST Spinal SystemK2m, Inc.20186—
+9K172115Navigated Instrument SystemOrthofix, Inc.20184—
+9K171321K2M Navigation InstrumentsK2m201711
+9K171425Concorde LiftMedos International SARL201782
+9K162921Navigated Instrument SystemOrthofix, Inc.20175—
+9K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+9K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+9K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+9K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+9K130194Acculif XL CageCoalign Innovations, Inc.20131—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+10K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+10K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+10K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+10K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+10K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+10K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+10K241895Cannulated PsiFGuardSpineguard20240—
+10K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+10K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+10K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+10K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+10K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+10K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+10K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+10K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+10K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+10K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+10K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+10K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+10K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+10K213815SiJoin®T3Vgi Medical, Inc.20230—
+10K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+10K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+10K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+10K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+10K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+10K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+10K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+10K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+10K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+10K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+10K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+10K201006K2M Navigation InstrumentsK2m, Inc.20200—
+10K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+10K182349Concorde LiftMedos International SARL20190—