510(k) Report

Devices descending from K984350

308 later devices reach VSP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K101070Expedium Spine SystemMedos International SARL20102601
+1K100757Tilock Pedicle Screw SystemGenesys Spine201091
+1K001080Spine System EvolutionAesculap, Inc.200062—
+1K993551Socon Spinal SystemAesculap, Inc.20000—
+1K990721Isolock Spinal SystemScien'Tx USA, Inc.199964—
+2K173508Everest Spinal SystemK2m20189—
+2K172469TiLock Modular Spinal SystemGenesys Spine20170—
+2K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+2K171838TiLock2 Spinal SystemGenesys Spine20174—
+2K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+2K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+2K103671Genesys Spine Tilock SystemGenesys Spine20118—
+2K040747Aladyn Rigid Spine PlateScient'X20040—
+3K252322SIros-X SystemGenesys Spine20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—