510(k) Report

Devices descending from K010658

667 later devices reach Modified Uss Fracture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K113666Xia 3 Spinal SystemStryker Spine2012251—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K113361Securis Spinal FixationCumtom Spine20120—
+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
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+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—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+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—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K172206NAJA™ Ligament Correction SystemCousin Biotech Sas20182—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—