510(k) Report

Devices descending from K962984

587 later devices reach Isola Pediatric Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K190418NuVasive® VersaTie® SystemNu Vasive, Incorporated20190—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K173506LigaPASSMedicrea International SA20189—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K171321K2M Navigation InstrumentsK2m201711
+5K172194Connector SystemOrthofix, Inc.2017162
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K161016Z-Clamp ISP SystemZavation, LLC20160—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+5K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K123138Pass LP Spinal SystemMedicrea International2013132—
+5K120838Synthes Matrix SystemSynthes Spine201216—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+5K120571Synthes Uss ConnectorSynthes Spine201274—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K241258Ingenix Spinal SystemIngenium Spine20240—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K233300POWEReam 1/4 DriveStryker Instruments20231—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—