510(k) Report

Devices descending from K962984

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+1K110348Universal Clamp Spinal Fixation SystemZimmer Spine201144—
+1K071668Orthobiom Spinal SystemParadigm Spine2008582—
+1K980761Synthes Spine Pediatric Rod SystemSynthes Spine19981—
+1K981113Pediatric PRCAcromed Corp.19981—
+2K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+2K172206NAJA™ Ligament Correction SystemCousin Biotech Sas20182—
+2K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K161267Response BandLoc Spinal FixationOrthoPediatrics Corp.201611
+2K151974Polaris Spinal SystemBiomet Spine201516—
+2K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K143350Nile Alternative FixationK2m, Inc.201510—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc.201423—
+2K133482Silc Fixation SystemGlobus Medical, Inc.201411—
+2K132395LigapassMedicrea International201323—
+2K132287Jazz SystemHogan Lovells US LLP201315—
+2K121541Jazz SystemImplanet, S.A.201227—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K113666Xia 3 Spinal SystemStryker Spine2012251—
+2K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010581—
+2K991552Synthes Pediatric Rod SystemSynthes (Usa)19990—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+3K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+3K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+3K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K200281The Gecko Spinal SystemOrtho Development Corporation20200—
+3K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.20200—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+3K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+3K160698LigaPASSMedicrea International SA201612—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K161265NuVasive® VersaTie SystemNu Vasive, Incorporated20163—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K151740JAZZ SystemImplanet, S.A.201512—
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K143759JAZZ SystemImplanet, S.A.201513—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K133617Jazz SystemImplanet, S.A.201414—
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+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—
+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—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+3K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011261—
+3K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc.2011269—
+3K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.2010261
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—