510(k) Report

Devices descending from K113138

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150481Cascadia Interbody SystemK2m, Inc.20154593
+1K133614Aleutian Ibf SystemK2m, Inc.2014527—
+1K122588Vusion CS PlusOrtho Development Corp.2013206—
+1K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+1K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+1K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+2K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+2K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+2K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+2K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+2K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+2K172941CASCADIA Interbody SystemK2m201852—
+2K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+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—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+2K163364MOJAVE Expandable Interbody SystemK2m201725—
+2K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+2K162264Cascadia Interbody SystemK2m, Inc.2016169—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K153621Juliet® TiSpineart2016751
+2K160125Cascadia Interbody SystemK2m2016315—
+2K160547Cascadia Interbody SystemK2m2016157—
+2K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+2K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+2K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+3K261049Scala® TLSpineart SA20260—
+3K2530413d Cage CervicalFims Co., Ltd.20260—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+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—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+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—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+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—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+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—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K211413BEE PLIF CageNGMedical GmbH20211—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+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—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K200429BEE CagesNGMedical GmbH202111—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+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—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K200312Tryptik TiSpineart20202—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+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—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+3K191134IB3D AlifMedicrea International SA20191—
+3K1803473d CageFims Co., Ltd.20190—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—