510(k) Report

Devices descending from K073364

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+5K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+5K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171321K2M Navigation InstrumentsK2m201711
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243693NEO Pedicle Screw System™Neo Medical SA20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232