510(k) Report

Devices descending from K944736

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+6K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+6K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182721Choice Spine Navigation SystemChoicespine, LP20192—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+6K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+6K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+6K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+6K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+6K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+6K151977icotec Pedicle SystemIcotec AG201630—
+6K153326Erisma-LP Spinal Fixation SystemClariance, Sas201651
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+6K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+6K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+6K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+6K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+6K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+6K121728Tiger Spine SystemCorelink, LLC201250—
+6K121172Reform Pedicle Screw SystemSpinal USA201233—
+6K121020Viper SystemDepuy Spine, Inc.201294—