510(k) Report

Devices descending from K992147

451 later devices reach Triple-Fix Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K153413PASS LP Spinal SystemMedicrea International SA20160—
+7K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+7K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+7K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+7K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+7K123138Pass LP Spinal SystemMedicrea International2013132—
+8K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+8K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+8K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K203452Nano FortiFix® SystemNanovis, LLC20200—
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+8K182721Choice Spine Navigation SystemChoicespine, LP20192—
+8K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+8K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+8K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+8K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+8K142798PASS LP Spinal SystemMedicrea International SA201584—
+8K150049PASS LP Spinal SystemMedicrea International20150—
+8K141398Pass LP Spinal SystemMedicrea International SA2015101
+8K140738Pass LP Spinal SystemMedicrea International201447—
+8K132574Pass LP Spinal SystemMedicrea International20130—
+8K132575Pass LP Spinal SystemMedicrea International20130—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—