510(k) Report

Devices descending from K042571

894 later devices reach Stryker Spine Avs TL Peek Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+1K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+1K051781Graftcage TLXOsteotech, Inc.20050Class I
+1K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+1K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005892—
+2K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K171140Matrixx SystemNexxt Spine, LLC2017145—
+2K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+2K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+2K131077Life Spine Plateau Spacer SystemLife Spine201310—
+2K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+2K122444Cervical CageEisertech, LLC201222—
+2K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+2K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+2K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+2K062132Avs PL Peek Spacer SystemStryker Spine2006243—
+2K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+2K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine2006270—
+2K053508Synfix-LRSynthes Spine Co.Lp2006391
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K210359Hexanium TLIFSpinevision, S.A.S.20211—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+3K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+3K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+3K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+3K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+3K133717Longbow Spacer SystemLife Spine20149—
+3K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+3K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+3K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+3K113478Plif CageEisertech, LLC2012269—
+3K112862Mecta-CMedacta International201114—
+3K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+3K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+3K110915Cervical CageEisertech, LLC201123—
+3K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+3K100889Endoskeleton TCTitan Spine, LLC2010455—
+3K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+3K091946Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XXStryker Spine20095—
+3K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K242303MOD-COrthomod, LLC20260—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+4K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K230329F3D Interbody SystemCorelink, LLC20230—