510(k) Report

Devices descending from K022285

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+8K203452Nano FortiFix® SystemNanovis, LLC20200—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+8K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+8K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+8K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+8K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+8K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+8K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+8K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+9K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+9K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+9K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K252437JAZZ Spinal SystemImplanet20250—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+9K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+9K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K240392JAZZ Spinal SystemImplanet20241—
+9K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+9K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+9K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+9K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+9K182182YUKON OCT Spinal SystemK2m20185—
+9K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+9K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+9K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+10K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+10K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+10K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+10K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+10K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+10K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+10K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+10K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+10K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+10K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+10K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+10K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+10K200896Solstice CCILife Spine, Inc.20200—
+10K193129Yukon OCT Spinal SystemK2m, Inc.202001
+10K183381Navigation Enabled InstrumentsStryker20191—
+11K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+11K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+11K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+11K232432E3D™-A Interbody SystemEvolution Spine20248—
+11K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+11K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+11K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+12K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+12K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+12K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+12K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+12K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+12K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+12K240368E3D™-A Interbody SystemEvolution Spine20247—
+12K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+12K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+12K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+12K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+12K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—