510(k) Report

Devices descending from K962984

587 later devices reach Isola Pediatric Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+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—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+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—
+4K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED 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—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+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—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+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—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173508Everest Spinal SystemK2m20189—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K173117NuVasive® VersaTie™ SystemNuvasive, Inc.20172—
+4K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K172021LigaPASSMedicrea International SA201711—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171881JAZZ Passer BandImplanet, S.A.20170—
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+4K170647Connector SystemOrthofix, Inc.201718—
+4K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K162764Jazz Frame SystemImplanet, S.A.20176—
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+4K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K140529Everest Spinal SystemK2m, LLC201431—