510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+8K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231479TriALTIS Spine SystemMedos International SARL20238—
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+8K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+8K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+8K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+8K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+8K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+8K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+8K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+8K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+8K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+8K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+8K230026SqualeImplanet, S.A.20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223418DeGen Impulse AM™ SystemDegen Medical20236—
+8K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+8K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+8K223251Hexanium PLIFSpinevision, S.A.S.20220—
+8K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+8K222561AlignAcuity Surgical Devices, LLC202214—
+8K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+8K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+8K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+8K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+8K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+8K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+8K220610SOLO-LAurora Spine, Inc.20220—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+8K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+8K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+8K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K220025ARx® Spinal SystemLife Spine, Inc.20220—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+8K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+8K213918DeGen Navigated InstrumentationDegen Medical20220—
+8K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+8K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+8K210573Velofix SA Cervical CageU&I Corporation20211—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K211740DualXAmplify Surgical, Inc.20211—
+8K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+8K201793EDEN Peek CageJmt Co., Ltd.20210—
+8K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+8K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+8K211413BEE PLIF CageNGMedical GmbH20211—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+8K210549ARx Spinal SystemLife Spine, Inc.20211—
+8K200919Idys ALIF 3DTiClariance20210—
+8K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+8K202032Idys LLIF 3DTiClariance, Sas20210—
+8K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+8K200429BEE CagesNGMedical GmbH202111—
+8K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+8K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+8K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—