510(k) Report

Devices descending from K052398

114 later devices reach Mesa Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+1K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+1K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+1K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+1K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+1K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+1K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+1K133402K2M Modular HooksK2m, Inc.20140—
+1K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+1K132361Everest Spinal SystemK2m, Inc.201334—
+1K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+1K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+1K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+1K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+1K072914Natural Bridge LP Transverse ConnectorsK2m, Inc.200865—
+2K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+2K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+2K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+2K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+2K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+2K143350Nile Alternative FixationK2m, Inc.201510—
+2K140529Everest Spinal SystemK2m, LLC201431—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K132757Everest Spinal SystemK2m, Inc.201341—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K131030Range Spinal SystemK2m, Inc.201334—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+2K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+2K120899Range Spinal System, Unit RodK2m, Inc.201235—
+2K120656Everest Spinal SystemK2m, Inc.201243—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K222789VADER® Pedicle System, G21 CementIcotec AG202352
+3K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K173508Everest Spinal SystemK2m20189—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+3K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K142360Everest Spinal SystemK2m, Inc.201522—
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141147Range Spinal SystemK2m, Inc.20141—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K232628VADER® Pedicle SystemIcotec AG20241—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+4K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+4K171321K2M Navigation InstrumentsK2m201711
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—