510(k) Report

Devices descending from K944736

598 later devices reach VSP (Variable Screw Placement) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K120696Tiger Spine SystemCorelink, LLC201241—
+6K080767Conquest Spinal SystemLife Spine200821—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+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—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K253249TriALTIS™ Spine SystemMedos International SARL20251—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+7K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K203023Pisces Spinal SystemOrtho Development Corporation20210—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+7K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+7K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+7K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K171582NEO Pedicle Screw System™Neo Medical SA20170—
+7K171321K2M Navigation InstrumentsK2m201711
+7K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+7K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+7K170647Connector SystemOrthofix, Inc.201718—
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+7K162367Erisma® LP MISClariance, Sas20162—
+7K161842Overwatch Spine SystemAmendia, Inc.201661
+7K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K151974Polaris Spinal SystemBiomet Spine201516—