510(k) Report

Devices descending from K952236

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+6K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+6K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+6K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+6K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+6K182721Choice Spine Navigation SystemChoicespine, LP20192—
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+6K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+6K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+6K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+6K180324Patriot Spinal Fixation SystemValorus Spine20180—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+6K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171321K2M Navigation InstrumentsK2m201711
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+6K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+6K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+6K151977icotec Pedicle SystemIcotec AG201630—
+6K153326Erisma-LP Spinal Fixation SystemClariance, Sas201651
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K151813Sniper Spine SystemSpine Wave, Inc.20159—
+6K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+6K143110GALAXY MIS Screw SystemBm Korea20152—
+6K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+6K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+6K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671