510(k) Report

Devices descending from K081297

239 later devices reach Vertex Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K173508Everest Spinal SystemK2m20189—
+5K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K161149PASS OCT Spinal SystemMedicrea International SA20160—
+5K160756PASS OCT Spinal SystemMedicrea International SA20160—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153169PASS OCT Patient Specific RodsMedicrea International20164—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+6K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K171321K2M Navigation InstrumentsK2m201711
+6K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K142360Everest Spinal SystemK2m, Inc.201522—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K151216Everest Spinal SystemK2m, Inc.201511—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—