510(k) Report

Devices descending from K073177

775 later devices reach Pioneer Intervertebral Fusion Device System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+6K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+6K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+6K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+6K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+6K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+6K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K222561AlignAcuity Surgical Devices, LLC202214—
+6K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+6K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K220610SOLO-LAurora Spine, Inc.20220—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+6K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+6K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+6K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K210728CONDUIT InstrumentsMedos International SARL20215—
+6K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K201585Monterey AL Interbody SystemStryker Corporation202044
+6K201087CORBEL SpacersGlobus Medical, Inc.202036—
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+6K192993Scarlet AL-TSpineart20201—
+6K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+6K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+6K182584Lucent® XPSpinal Elements, Inc.20183—