510(k) Report

Devices descending from K030377

391 later devices reach Modification to Synthes Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K141147Range Spinal SystemK2m, Inc.20141—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K252437JAZZ Spinal SystemImplanet20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240392JAZZ Spinal SystemImplanet20241—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K231515MySpine Cervical GuidesMedacta International S.A.20230—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+7K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K133402K2M Modular HooksK2m, Inc.20140—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—