510(k) Report

Devices descending from K071495

539 later devices reach Expedium 4.5MM Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K182182YUKON OCT Spinal SystemK2m20185—
+6K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+6K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+6K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+6K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K171321K2M Navigation InstrumentsK2m201711
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+6K162764Jazz Frame SystemImplanet, S.A.20176—
+6K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+6K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+7K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+7K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+7K191217Jazz PFImplanet, S.A.20190—
+7K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+7K183381Navigation Enabled InstrumentsStryker20191—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K171881JAZZ Passer BandImplanet, S.A.20170—
+7K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+7K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—