510(k) Report

Devices descending from K051454

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K172065Scarlet AC-TSpineart20172—
+3K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+3K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+3K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+3K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K153621Juliet® TiSpineart2016751
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+3K141798Sypher Spacer SystemBiogennix, LLC20151—
+3K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+3K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+3K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+3K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+3K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+3K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+3K122021Sterispine LC CageSafe Orthopaedics20122—
+3K120576Zavation Ibf SystemZavation, LLC201232—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K221578Hexanium ACIFSpinevision, S.A.S.20224—
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K200919Idys ALIF 3DTiClariance20210—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K210359Hexanium TLIFSpinevision, S.A.S.20211—