510(k) Report

Devices descending from K101302

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+1K133614Aleutian Ibf SystemK2m, Inc.2014527—
+1K133126K7 Lumbar SpacersK7, LLC20131—
+1K130699Aleutian Spinal SystemK2m, Inc.2013570—
+1K123388K7C SpacerK7, LLC20130—
+1K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+1K110843Aleutian Spacer SystemK2m, Inc.2011589—
+1K103169AleuttianK2m, Inc.2011572—
+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—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K212831MectaLIF ExtensionMedacta International S.A.20211—
+2K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+2K202380Born PT-LIF Cage HASpineworxx AG20210—
+2K200312Tryptik TiSpineart20202—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+2K172941CASCADIA Interbody SystemK2m201852—
+2K172065Scarlet AC-TSpineart20172—
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K163364MOJAVE Expandable Interbody SystemK2m201725—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K160125Cascadia Interbody SystemK2m2016315—
+2K160547Cascadia Interbody SystemK2m2016157—
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+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—
+2K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+2K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+2K112664Zavation Ibf SystemsZavation, LLC201137—
+3K261049Scala® TLSpineart SA20260—
+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—
+3K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230583Tryptik TiSpineart SA20231—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+3K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+3K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+3K171312FortiCore®Nanovis, LLC20183—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—