510(k) Report

Devices descending from K980485

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K141509Isola and Expedium Growing Spine SystemsMedos Sarl20146—
+1K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+1K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+1K101070Expedium Spine SystemMedos International SARL20102601
+1K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+1K042928Modification to Global Spinal Fixation SystemU&I Corp.2005124—
+1K032604Gii Spinal Fixation SystemCo-Ligne AG20045—
+1K022285Modification to Isola Spinal SystemDepuyacromed2002403—
+1K013447Isobar Spinal SystemScien'Tx USA, Inc.200238—
+1K013440Isobar Spinal SystemScien'Tx USA, Inc.200184—
+1K010576Monarch Spine SystemDepuyacromed2001596—
+1K992738Isobar Spinal SystemEncore Orthopedics, Inc.199963—
+2K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+2K210306GII Spinal Fixation SystemColigne AG20210—
+2K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+2K182240PASS LP Spinal SystemMedicrea International SA20182—
+2K173508Everest Spinal SystemK2m20189—
+2K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+2K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+2K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+2K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc.201411
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K130655Response Spine SystemOrthoPediatrics Corp.201317—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121250OP Spine SystemOrthoPediatrics Corp.201218—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K111571Viper SystemsJohnson & Johnson2011203—
+2K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2011123—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+2K083567Gii Spinal Fixation System, Gii-TI-Poly Axial ScrewCo-Ligne AG20091—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+2K073126Expedium Spine SystemDepuy Spine, Inc.2007304—
+2K062513Apex Spine SystemSpinecraft, Inc.2006179—
+2K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+2K051089Gii Spinal Fixation SystemCo-Ligne AG20054—
+2K043001MX Polyaxial Pedicle ScrewScient'X200437—
+2K024348Monarch Spine SystemDepuyacromed2003578—
+2K023438Modification to Monarch Spine SystemDepuyacromed20024—
+2K021148Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed2002496—
+2K013441Isola Polyaxial WasherDepuyacromed2001262—
+2K001080Spine System EvolutionAesculap, Inc.200062—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K252437JAZZ Spinal SystemImplanet20250—
+3K243249TriALTIS™ Spine SystemMedos International SARL20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240392JAZZ Spinal SystemImplanet20241—
+3K233105RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp.20240—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.20164—
+3K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—