510(k) Report

Devices descending from K101301

474 later devices reach Stalif Midline through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K191134IB3D AlifMedicrea International SA20191—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K190680Favo S-TlifSilony Medical GmbH20190—
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+4K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+5K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+5K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+5K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+5K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K223326Axiom PSR SystemRestor3D202301
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+5K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+5K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+5K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+5K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—