510(k) Report

Devices descending from K944756

491 later devices reach Isola Open and Closed Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+6K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+6K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+7K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+7K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K181188EVEREST Spinal SystemK2m, Inc.20186—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133