510(k) Report

Devices descending from K032945

248 later devices reach Simplex X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+1K161114HIGH V+Teknimed Sas2017421
+1K093477Shield Kyphoplasty SystemSoteira, Inc.20110—
+1K080108Cortoss Bone Augmentation MaterialOrthovita, Inc.200904
+1K072118Stryker Vertaplex Radiopaque Bone CementStryker Corp.200763—
+1K070015Cobalt V Radiopaque Vertebroplasty Bone CementBiomet Manufacturing Corp20070—
+1K053336Staxx FX SystemSpine Wave, Inc.200612—
+1K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd.20061768
+1K042691Vertefix Vertebroplasty Procedure SetCook, Inc.2005189—
+1K043406Vertebroplastic Radiopaque Bone CementDepuy Spine, Inc.20053—
+1K042415Mendec SpineTecres S.P.A.200528—
+1K043518Radiopaque Bone CementCardinalhealth200527—
+1K042168CONCORD Radiopaque Bone CementGlobus Medical, Inc.20056—
+1K042947Parallax Acrylic Resin with Tracers, Model KP-Par-003Arthrocare Corp.20043—
+1K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc.20042092
+2K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed, Ltd.20242—
+2K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+2K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+2K192403VK100 Percutaneous Vertebral Augmentation SystemBonwrx, Ltd.20190—
+2K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+2K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+2K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+2K162618CONCORD Plus Radiopaque Bone CementGlobus Medical, Inc.20175—
+2K151125AVAflex Vertebral Balloon SystemCare Fusion20151—
+2K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+2K131820Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax…Care Fusion20138—
+2K131824Avaflex Vertebral Balloon SystemCare Fusion20133—
+2K122175Mendec Spine HV, Mendec Spine HV SystemTecres S.P.A.20131—
+2K112907Confidence High Viscosity Spinal Cement, 16G / 20GMedos International SARL20110—
+2K102397Kyphon Xpede Bone CementMedtronic2011165—
+2K103064Avamax Vertebral BalloonCare Fusion201122—
+2K093828Kyph X HV-R Bone CementMedtronic, Inc.2010167—
+2K093463Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion201023—
+2K091606Vertaplex HV (Single Pack and Dual Pack)Stryker Corp.200959—
+2K090211Inflatable Bone TampCardinal Health, Inc.200924—
+2K071375Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)Disc-O-Tech Medical Technologies, Ltd.20070—
+2K071927Modification to Vertebroplastic Radiopaque Bone CementDepuy Spine, A Johnson & Johnson Company20072—
+2K070527Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek20071—
+2K063606Modification to Staxx FX SystemSpine Wave, Inc.200711—
+2K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek200717—
+2K063438VspspnTecres S.P.A.20070—
+2K063067Confidence Fenestrated Introducer NeedleDisc-O-Tech Medical Technologies, Ltd.20064—
+2K062452Kit Mendec Spine and Delivery SystemTecres S.P.A.200618—
+2K062424Confidence EX High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd.20067—
+2K061531Space Cpsxl Bone CementDfine, Inc.20062—
+2K043593Spine-Fix Biomimetic Bone CementTeknimed, S.A.200622—
+2K053180Parallax Acrylic Resin Cartridge with TracersArthrocare Corp.20061—
+2K050864Parallax Acrylic Resin with Tracers TAArthrocare Corp.20051—
+3K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+3K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed, Ltd.20260—
+3K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed, Ltd.20250—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+3K223294SpineJack® Expansion KitStryker Instruments20221—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K200763Osteo-site Vertebral BalloonIzi Medical20200—
+3K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K181262SpineJack Expansion KitVexim SA20184—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K172871SpineKure Kyphoplasty SystemHanchang Co., Ltd.20180—
+3K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+3K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation20160—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K151227KYPHON XPEDE Bone CementMedtronic201554—
+3K150523AVAmax Vertebral BalloonCare Fusion20151—
+3K150582Vertaplex® High Viscosity (HV) Radiopaque Bone CementStryker Corporation2015531
+3K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc.2015162—
+3K141419ZvplastyZavation, LLC2014036
+3K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+3K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC20130—
+3K122533Osseoflex SB Inflatable Bone TampOsseon Therapeutics, Inc.20128—
+3K113452Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc.20120—
+3K110604VBB SystemSynthes201111
+3K103816Cohesion Bone CementTeknimed Sas20110—
+3K103433F20Teknimed, S.A.201118—
+3K080873Opacity + Bone CementTeknimed, S.A.200820—
+3K072133Avaflex Vertebral Augmentation NeedleCardinal Health, Inc.20073—
+3K072496Modification to Space Cpsxl Bone CementDfine, Inc.20071—
+3K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.200710—
+3K070351Space 360 Delivery SystemDfine, Inc.20071—
+3K060425Parallax Acrylic Resin Cartridge with Tracers-TAArthrocare Corp.20060—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K250637VCFix Spinal SystemAmber Implants20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K240084V-STRUT® Vertebral ImplantHyprevention20240—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K202393SpineJack Expansion KitStryker Corporation20203—