510(k) Report

Devices descending from K151726

139 later devices reach AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+1K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+1K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+1K172419Velofix™ TLIF CageU&I Corporation20172—
+1K162262Tritanium® PL CageStryker2016132—
+2K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+2K183243Velofix TLIF CageU&I Corporation20190—
+2K181829Velofix TLIF CageU&I Corporation20181—
+2K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+2K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+3K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K200312Tryptik TiSpineart20202—
+3K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K230583Tryptik TiSpineart SA20231—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+7K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+7K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+7K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+7K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+7K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+7K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+8K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+8K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+8K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+8K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+8K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+9K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—