510(k) Report

Devices descending from K944756

491 later devices reach Isola Open and Closed Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+1K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+2K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+2K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+2K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+2K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+2K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+2K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+2K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+2K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+2K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+2K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+2K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+2K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K173508Everest Spinal SystemK2m20189—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+3K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+3K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131030Range Spinal SystemK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+3K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+3K120899Range Spinal System, Unit RodK2m, Inc.201235—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K110551Expedium Spine SystemJohnson & Johnson20111—
+3K111571Viper SystemsJohnson & Johnson2011203—
+3K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—