510(k) Report

Devices descending from K030103

658 later devices reach Summit Oct Spinal System Minipolyaxial Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182721Choice Spine Navigation SystemChoicespine, LP20192—
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+5K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+5K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+5K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+5K151755OASYS (r) SystemStryker Corporation201533—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+5K131784Range Spinal SystemK2m, Inc.201334—
+5K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+5K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+5K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+5K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K121020Viper SystemDepuy Spine, Inc.201294—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K080767Conquest Spinal SystemLife Spine200821—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K232167VySpan™ PCT SystemVy Spine, LLC20230—