510(k) Report

Devices descending from K080971

406 later devices reach Spinesmith Cimplicity Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+2K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+2K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+2K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+2K141005Z-Link CervicalZavation, LLC20144—
+2K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K190885Elevation Spine Saber-C SystemElevation Spine201925—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+3K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+3K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K260660SABER-C SystemElevation Spine20261—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250540SABER-C SystemElevation Spine20252—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K171312FortiCore®Nanovis, LLC20183—
+4K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K263049SABER-C SystemElevation Spine20260—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261049Scala® TLSpineart SA20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—