510(k) Report

Devices descending from K952236

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K210549ARx Spinal SystemLife Spine, Inc.20211—
+8K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+8K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+8K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+8K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+8K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+8K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+8K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K182182YUKON OCT Spinal SystemK2m20185—
+8K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+8K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+8K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+8K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+8K162921Navigated Instrument SystemOrthofix, Inc.20175—
+8K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+8K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+8K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+8K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K243693NEO Pedicle Screw System™Neo Medical SA20240—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K233684TriALTIS™ Spine SystemMedos International SARL20234—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+9K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+9K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K223494CD Horizon Spinal SystemMedtronic202317—
+9K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+9K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K200896Solstice CCILife Spine, Inc.20200—
+9K193129Yukon OCT Spinal SystemK2m, Inc.202001
+9K183381Navigation Enabled InstrumentsStryker20191—
+9K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+9K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+9K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+9K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+10K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K253331PressON Spinal Fixation SystemNexus Spine20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K242042TriALTIS™ Spine SystemMedos International SARL20241—
+10K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—