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
+1K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+1K042143Excella-M Spinal SystemInnovasis, Inc.20046—
+1K992739Click'xSynthes Spine20009121
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+2K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+2K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+2K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120571Synthes Uss ConnectorSynthes Spine201274—
+2K120696Tiger Spine SystemCorelink, LLC201241—
+2K113149Synthes Uss ConnectorsSynthes Spine201293—
+2K113044Synthes MirsSynthes Spine2011933
+2K110604VBB SystemSynthes201111
+2K111358Synthes UssSynthes Spine2011151—
+2K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine2011348—
+2K100952Modification to Synthes Matrix SystemSynthes Spine2010314Class I
+2K092420KRD1 Pedicle Screw SystemSpinefrontier, Inc.200962
+2K090605ClampfixSynthes (Usa)2009349—
+2K082914ClampfixSynthes Spine2008350—
+2K082572Uss Iliosacral, Uss PolyaxialSynthes Spine2008659—
+2K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+2K072685Ngarde SystemN Spine, Inc.200709
+2K052123Synthes Pangea SystemSynthes (Usa)2005774—
+2K040442Protex Stabilization SystemGlobus Medical, Inc.2004551—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170654USS SystemSynthes USA Products, LLC201789—
+3K162143FixxSure® X-LinkInnovasis, Inc.20160—
+3K153152Syzygy Stabilization SystemAmendia, Inc.201602
+3K153404Zavation Spinal SystemZavation, LLC20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+3K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+3K141850Flospine Pedicle Screw SystemFlospine20140—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+3K130146Synthes Synflate Vertevral Balloon SystemSynthes (Usa), LLC20130—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K112684Mont Blanc Pedicle Screw SystemsQualgenix20125—
+3K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+3K113361Securis Spinal FixationCumtom Spine20120—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K110633Lancer Pedicle Screw SystemSpinal Solutions, LLC201108
+3K110655Mahe Perfect Spine- Pedicle Screw SystemMahe Medical GmbH20110—
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+3K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010581—
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K100634Synthes Matrix SystemSynthes (Usa)2010316—
+3K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+3K091717Any Plus Spinal Fixation SystemGS Medical Co., Ltd.2010130—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K080241DDS Stabilization SystemParadigm Spine, LLC20085—
+3K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc.2008209—
+3K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc.20082773
+3K073517H-Link Integrated RodGlobus Medical, Inc.20080—
+3K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+3K061202Revere Stabilization SystemGlobus Medical, Inc.2006547—
+3K052069Protex Stabilization System with Additional ComponentesGlobus Medical, Inc.2005549—
+3K042953Modification to Protex Stabilization SystemGlobus Medical, Inc.20040—