510(k) Report

Devices descending from K990148

1,867 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+8K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+8K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+8K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+8K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+8K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+8K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+8K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+8K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+8K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+8K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+8K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+8K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+9K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K182721Choice Spine Navigation SystemChoicespine, LP20192—
+9K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+9K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+9K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+9K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+9K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+9K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+10K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+10K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+10K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+10K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+10K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+10K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+10K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+10K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+10K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+10K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+10K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+10K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+10K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+10K221244CD Horizon™ Spinal SystemMedtronic202220—
+10K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+10K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+10K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+10K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+10K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+10K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+10K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+10K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+10K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+10K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+10K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+10K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+10K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+10K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+10K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+10K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+10K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+10K172115Navigated Instrument SystemOrthofix, Inc.20184—
+10K162921Navigated Instrument SystemOrthofix, Inc.20175—
+10K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+11K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+11K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+11K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+11K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+11K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+11K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+11K241895Cannulated PsiFGuardSpineguard20240—
+11K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+11K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+11K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+11K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+11K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+11K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+11K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+11K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+11K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+11K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+11K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+11K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+11K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+11K213815SiJoin®T3Vgi Medical, Inc.20230—
+11K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+11K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+11K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+11K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—