510(k) Report

Devices descending from K133614

527 later devices reach Aleutian Ibf System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+1K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+1K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+1K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+1K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+1K172941CASCADIA Interbody SystemK2m201852—
+1K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+1K163364MOJAVE Expandable Interbody SystemK2m201725—
+1K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+1K160125Cascadia Interbody SystemK2m2016315—
+1K150481Cascadia Interbody SystemK2m, Inc.20154593
+1K142487Chesapeake Stabilization SystemK2m, Inc.201571
+1K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+1K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+2K261049Scala® TLSpineart SA20260—
+2K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+2K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+2K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+2K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+2K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+2K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+2K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+2K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+2K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+2K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+2K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+2K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+2K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+2K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+2K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+2K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+2K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+2K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+2K182477Cervical SpacerAdditive Implants, LLC201915—
+2K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+2K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+2K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+2K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+2K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+2K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+2K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+2K171312FortiCore®Nanovis, LLC20183—
+2K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+2K171140Matrixx SystemNexxt Spine, LLC2017145—
+2K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+2K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+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—
+2K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+2K162264Cascadia Interbody SystemK2m, Inc.2016169—
+2K153621Juliet® TiSpineart2016751
+2K153436LATERAL Spine Truss System4Web, Inc.20165—
+2K160547Cascadia Interbody SystemK2m2016157—
+2K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+3K2530413d Cage CervicalFims Co., Ltd.20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+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—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+3K223326Axiom PSR SystemRestor3D202301
+3K223231Ti-Largo Cervical Interbody SystemFlospine20230—