510(k) Report

Devices descending from K993030

584 later devices reach Modification to Isola Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111410Nuvasive Long Lateral Spinal SystemNuvasive, Inc.20111—
+1K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+1K021335Monarch Spine SystemDepuyacromed2002581—
+2K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K122081Nuvasive Long Lateral Spinal SystemNuvasive, Inc.20130—
+2K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+2K033512Procyon Spinal SystemNas Medical Technologies, Inc.20040—
+2K024348Monarch Spine SystemDepuyacromed2003578—
+2K023438Modification to Monarch Spine SystemDepuyacromed20024—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+3K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+3K101070Expedium Spine SystemMedos International SARL20102601
+3K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc.2010178—
+3K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+3K073126Expedium Spine SystemDepuy Spine, Inc.2007304—
+3K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+3K062513Apex Spine SystemSpinecraft, Inc.2006179—
+3K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc.2005495—
+4K243249TriALTIS™ Spine SystemMedos International SARL20250—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K173508Everest Spinal SystemK2m20189—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K170647Connector SystemOrthofix, Inc.201718—
+4K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K132603Apex Spine SystemSpinecraft, LLC201325—
+4K130877Expedium Spine SystemMedos International SARL20138—
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K121568Dali Spinal Fixation SystemAccel Spine20121—
+4K120469Erisma-LPClariance20126—
+4K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+4K110551Expedium Spine SystemJohnson & Johnson20111—
+4K110906Apex Spine SystemSpinecraft, LLC2011103—
+4K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+4K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+4K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+4K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+4K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+4K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+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—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+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—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+5K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—