510(k) Report

Devices descending from K001864

733 later devices reach Synthes Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+4K153169PASS OCT Patient Specific RodsMedicrea International20164—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201513—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+4K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+4K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+4K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K140734Nextgen Altius Oct SystemEbi, LLC20140—
+4K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota20141—
+4K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+4K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+4K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+4K130877Expedium Spine SystemMedos International SARL20138—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K120998Solstice Cross ConnectorLife Spine20121—
+4K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K113346Neon SystemUlrich GmbH & Co. KG20121—
+4K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+4K111719Oasys Spinal SystemStryker Spine201239—
+4K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+4K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+4K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+4K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+4K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+4K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+4K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+4K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+4K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+4K101183Modification to: Oasys SystemStryker Spine20100—
+4K101070Expedium Spine SystemMedos International SARL20102601
+4K093670Modification to: Oasys SystemStryker Spine201041Class I
+4K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+4K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+4K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+4K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+4K080143Modification to Stryker Spine Oasys SystemStryker Spine200843—
+4K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+4K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+4K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+4K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K230614Cortium™Ulrich Medical USA20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K223852VySpan™ PCT SystemVy Spine, LLC20231—