510(k) Report

Devices descending from K073440

126 later devices reach Foundation Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162496Foundation 3D InterbodyCorelink, LLC201782—
+1K150847Foundation Interbody DevicesCorelink, LLC201529—
+1K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+1K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+1K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+2K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+2K230329F3D Interbody SystemCorelink, LLC20230—
+2K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+2K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+2K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+2K183064TxTi IBF SystemInnovasis, Inc.2019481
+2K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+2K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+2K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+2K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+2K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+2K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+2K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+2K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K223326Axiom PSR SystemRestor3D202301
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+3K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+3K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+3K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K183243Velofix TLIF CageU&I Corporation20190—