510(k) Report

Devices descending from K022285

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+1K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+1K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+1K073126Expedium Spine SystemDepuy Spine, Inc.2007304—
+2K243249TriALTIS™ Spine SystemMedos International SARL20250—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K151974Polaris Spinal SystemBiomet Spine201516—
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+2K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K130655Response Spine SystemOrthoPediatrics Corp.201317—
+2K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121250OP Spine SystemOrthoPediatrics Corp.201218—
+2K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+2K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+2K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+3K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+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—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+3K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061