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
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132303Implanet Spine SystemImplanet, S.A.201315—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+3K113666Xia 3 Spinal SystemStryker Spine2012251—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011261—
+3K110348Universal Clamp Spinal Fixation SystemZimmer Spine201144—
+3K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc.2011269—
+3K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.2010261
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—