510(k) Report

Devices descending from K051246

834 later devices reach Construx Mini Peek VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K223251Hexanium PLIFSpinevision, S.A.S.20220—
+4K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K221578Hexanium ACIFSpinevision, S.A.S.20224—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+4K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+4K210573Velofix SA Cervical CageU&I Corporation20211—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+4K201087CORBEL SpacersGlobus Medical, Inc.202036—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K190721LongBow TiLife Spine, Inc.20190—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+4K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+4K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+4K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—