510(k) Report

Devices descending from K963045

662 later devices reach Synthes (U.S.a.) Universal Sacral System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120838Synthes Matrix SystemSynthes Spine201216—
+1K120928Synthes Matrix SystemSynthes Spine20120—
+1K120571Synthes Uss ConnectorSynthes Spine201274—
+1K113149Synthes Uss ConnectorsSynthes Spine201293—
+1K113044Synthes MirsSynthes Spine2011933
+1K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine2011348—
+1K100952Modification to Synthes Matrix SystemSynthes Spine2010314Class I
+1K100634Synthes Matrix SystemSynthes (Usa)2010316—
+1K090605ClampfixSynthes (Usa)2009349—
+1K082914ClampfixSynthes Spine2008350—
+1K082572Uss Iliosacral, Uss PolyaxialSynthes Spine2008659—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+2K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+2K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+2K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K170654USS SystemSynthes USA Products, LLC201789—
+2K153404Zavation Spinal SystemZavation, LLC20161—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K141850Flospine Pedicle Screw SystemFlospine20140—
+2K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+2K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+2K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K123134Easyspine SystemLdr Spine USA, Inc.20131—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K113361Securis Spinal FixationCumtom Spine20120—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K111358Synthes UssSynthes Spine2011151—
+2K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010581—
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173508Everest Spinal SystemK2m20189—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—