510(k) Report

Devices descending from K090816

756 later devices reach Stryker Spine Avs PL Peek Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+5K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+5K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K223326Axiom PSR SystemRestor3D202301
+5K230583Tryptik TiSpineart SA20231—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223418DeGen Impulse AM™ SystemDegen Medical20236—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+5K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+5K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+5K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+5K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K192993Scarlet AL-TSpineart20201—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K191134IB3D AlifMedicrea International SA20191—
+5K1803473d CageFims Co., Ltd.20190—
+5K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K183092Kuros TLIF CageKuros Biosciences B.V20190—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+5K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+5K182584Lucent® XPSpinal Elements, Inc.20183—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K181829Velofix TLIF CageU&I Corporation20181—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K181014Tritanium PL CageStryker Spine2018137—
+5K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+5K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—