510(k) Report

Devices descending from K982320

538 later devices reach Depuy Motech Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K151813Sniper Spine SystemSpine Wave, Inc.20159—
+5K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+5K143110GALAXY MIS Screw SystemBm Korea20152—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+5K132603Apex Spine SystemSpinecraft, LLC201325—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K130176Firebird Spinal Fixation SystemOrthofix20135—
+5K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+5K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+5K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+5K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+5K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+5K083743Capsure PS SystemSpine Wave, Inc.20093—
+5K080767Conquest Spinal SystemLife Spine200821—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K240963Spinal SystemTeslake, Inc.20240—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K171321K2M Navigation InstrumentsK2m201711
+6K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+6K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+6K152174Sniper Spine SystemSpine Wave, Inc.20158—
+6K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+6K150417Astra Spine SystemSpinecraft, LLC201521—
+6K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—