510(k) Report

Devices descending from K080281

188 later devices reach Pathway through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160631Keos Lumbar IBFDKeos20161—
+1K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+1K111774Pathway Model 07XXXXCustom Spine201115—
+2K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+2K193174Keos Lumbar IBFDKeos20190—
+2K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+2K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+2K143143Pathway ElifCustom Spine, Inc.201514—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+3K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+3K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+3K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+3K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+3K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+3K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+4K200312Tryptik TiSpineart20202—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K191134IB3D AlifMedicrea International SA20191—
+4K1803473d CageFims Co., Ltd.20190—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+5K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K223326Axiom PSR SystemRestor3D202301
+5K230583Tryptik TiSpineart SA20231—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K230329F3D Interbody SystemCorelink, LLC20230—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+7K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—