510(k) Report

Devices descending from K040168

239 later devices reach Modification to Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052170Seaspine VBR SystemSeaspine, Inc.200513—
+1K050861Peek CasInterpore Cross Intl.2005224—
+2K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+2K091381Ibex Spinal SystemEbi, L.P.2009181—
+2K071726ZUMASeaspine, Inc.200712—
+2K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K124034Mectalif AnteriorMedacta International201311—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K102315Staxx XDL SystemSpine Wave, Inc.20113—
+3K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+3K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+4K133207Staxx (R) SystemSpine Wave, Inc.20131—
+4K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+4K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+5K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+5K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+5K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+5K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+6K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+6K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+6K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+7K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+7K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+7K230329F3D Interbody SystemCorelink, LLC20230—
+7K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+7K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+7K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201585Monterey AL Interbody SystemStryker Corporation202044
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200312Tryptik TiSpineart20202—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+7K191134IB3D AlifMedicrea International SA20191—
+7K1803473d CageFims Co., Ltd.20190—
+7K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+8K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—