510(k) Report

Devices descending from K032394

230 later devices reach Stryker Spine Oasys System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182182YUKON OCT Spinal SystemK2m20185—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+4K152211PCT SystemCentinel Spine, Inc.20150—
+4K151755OASYS (r) SystemStryker Corporation201533—
+4K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+4K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232167VySpan™ PCT SystemVy Spine, LLC20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+5K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+5K153439PathLoc-C Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20160—
+5K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K173508Everest Spinal SystemK2m20189—
+6K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K141147Range Spinal SystemK2m, Inc.20141—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—