510(k) Report

Devices descending from K040442

551 later devices reach Protex Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K160362Z-Span Plate SystemZavation, LLC20163—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K113058Tiger Spine SystemCorelink, LLC201281—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+6K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+6K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+6K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+6K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+6K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+6K200896Solstice CCILife Spine, Inc.20200—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K193129Yukon OCT Spinal SystemK2m, Inc.202001
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K183381Navigation Enabled InstrumentsStryker20191—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—