510(k) Report

Devices descending from K013444

94 later devices reach Isobar Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+1K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+1K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+1K110321Tiger Spine SystemCorelink, LLC201183—
+1K062912Scient'x Spinal SystemScient'X200736—
+1K033150Art Posterior Spinal SystemAdvanced Medical Technologies AG20041—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+2K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K120696Tiger Spine SystemCorelink, LLC201241—
+2K113058Tiger Spine SystemCorelink, LLC201281—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151977icotec Pedicle SystemIcotec AG201630—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+3K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K203023Pisces Spinal SystemOrtho Development Corporation20210—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+4K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K232628VADER® Pedicle SystemIcotec AG20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—