510(k) Report

Devices descending from K990745

916 later devices reach Modification to Synthes Universal Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+4K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+4K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K203023Pisces Spinal SystemOrtho Development Corporation20210—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+4K173508Everest Spinal SystemK2m20189—
+4K172546AnyPlus® Spinal Fixation SystemGS Medical Co., Ltd.201712—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150185Mont Blanc Spinal SystemSpineway20154—
+4K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—