510(k) Report

Devices descending from K112316

537 later devices reach 4-Web Alif Spinal Truss System (STS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180695FBC 921 (Alif)Fbc Device Aps20180—
+1K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+1K170341Medussa-PL CageMedyssey USA, Inc.20174—
+1K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+1K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+1K153436LATERAL Spine Truss System4Web, Inc.20165—
+1K150481Cascadia Interbody SystemK2m, Inc.20154593
+1K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+1K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+1K1421124WEB Spinal Implant Products4Web, Inc.201433—
+1K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K223654Medussa-PL CageMedyssey USA, Inc.20220—
+2K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+2K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+2K200283Medussa-PL CageMedyssey USA, Inc.20200—
+2K191134IB3D AlifMedicrea International SA20191—
+2K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+2K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+2K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+2K172941CASCADIA Interbody SystemK2m201852—
+2K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+2K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+2K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+2K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+2K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+2K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+2K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+2K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K163364MOJAVE Expandable Interbody SystemK2m201725—
+2K162264Cascadia Interbody SystemK2m, Inc.2016169—
+2K153621Juliet® TiSpineart2016751
+2K160125Cascadia Interbody SystemK2m2016315—
+2K160547Cascadia Interbody SystemK2m2016157—
+2K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+2K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+3K261049Scala® TLSpineart SA20260—
+3K2530413d Cage CervicalFims Co., Ltd.20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+3K223326Axiom PSR SystemRestor3D202301
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+3K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+3K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K211413BEE PLIF CageNGMedical GmbH20211—
+3K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K200429BEE CagesNGMedical GmbH202111—
+3K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K200316UNiD IB3D ALIFMedicrea International SA20200—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+3K200312Tryptik TiSpineart20202—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+3K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K191796Neo Cage SystemNeo Medical SA20190—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+3K1803473d CageFims Co., Ltd.20190—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—