510(k) Report

Devices descending from K030383

410 later devices reach Modification to Moss Miami Spinal System Polyaxial Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K151813Sniper Spine SystemSpine Wave, Inc.20159—
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+4K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+4K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+4K083743Capsure PS SystemSpine Wave, Inc.20093—
+4K080767Conquest Spinal SystemLife Spine200821—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+5K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K171321K2M Navigation InstrumentsK2m201711
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K172194Connector SystemOrthofix, Inc.2017162
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K152174Sniper Spine SystemSpine Wave, Inc.20158—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+5K090320Conquest Spinal SystemLife Spine20092—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—