510(k) Report

Devices descending from K990118

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170647Connector SystemOrthofix, Inc.201718—
+4K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K131833Centurion Poct SystemOrthofix, Inc.20142—
+4K132603Apex Spine SystemSpinecraft, LLC201325—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130176Firebird Spinal Fixation SystemOrthofix20135—
+5K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K240963Spinal SystemTeslake, Inc.20240—
+5K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K232628VADER® Pedicle SystemIcotec AG20241—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K172194Connector SystemOrthofix, Inc.2017162
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+5K150417Astra Spine SystemSpinecraft, LLC201521—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K190751Connector SystemOrthofix, Inc.20193—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.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—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—