510(k) Report

Devices descending from K952236

702 later devices reach Isola System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K121568Dali Spinal Fixation SystemAccel Spine20121—
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+4K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+4K110906Apex Spine SystemSpinecraft, LLC2011103—
+4K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+4K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+4K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+4K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+4K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+4K100757Tilock Pedicle Screw SystemGenesys Spine201091
+4K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+4K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc.2010178—
+4K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+4K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+4K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+4K083567Gii Spinal Fixation System, Gii-TI-Poly Axial ScrewCo-Ligne AG20091—
+4K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+4K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+4K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+4K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+4K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+4K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+4K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+4K081228Capsure PS (R) Spine SystemSpine Wave, Inc.200839—
+4K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+4K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+4K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+4K073126Expedium Spine SystemDepuy Spine, Inc.2007304—
+4K072685Ngarde SystemN Spine, Inc.200709
+4K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+4K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+4K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+4K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+4K051089Gii Spinal Fixation SystemCo-Ligne AG20054—
+4K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc.2005495—
+4K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+4K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K243249TriALTIS™ Spine SystemMedos International SARL20250—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+5K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+5K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+5K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—