510(k) Report

Devices descending from K952236

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+1K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998413—
+1K981714Timx Low Back System Titanium MX Rod Based Low Back SystemAcromed Corp.1998597—
+1K981113Pediatric PRCAcromed Corp.19981—
+2K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+2K071743Pillar Pedicle Screw SystemThe 4th Column, LLC20070—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003410—
+2K010576Monarch Spine SystemDepuyacromed2001596—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K101070Expedium Spine SystemMedos International SARL20102601
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+3K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+3K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+3K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20071801
+3K072081Zodiac Dynamo Semi-Rigid Spinal SystemAlphatec Spine, Inc.20071—
+3K063668Roc Lumbar SystemAlphatec Spine, Inc.20070—
+3K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742—
+3K062513Apex Spine SystemSpinecraft, Inc.2006179—
+3K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+3K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+3K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462—
+3K032604Gii Spinal Fixation SystemCo-Ligne AG20045—
+3K024348Monarch Spine SystemDepuyacromed2003578—
+3K023438Modification to Monarch Spine SystemDepuyacromed20024—
+3K021148Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed2002496—
+3K013441Isola Polyaxial WasherDepuyacromed2001262—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K210306GII Spinal Fixation SystemColigne AG20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K173508Everest Spinal SystemK2m20189—
+4K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132603Apex Spine SystemSpinecraft, LLC201325—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130877Expedium Spine SystemMedos International SARL20138—