510(k) Report

Devices descending from K002652

216 later devices reach Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043406Vertebroplastic Radiopaque Bone CementDepuy Spine, Inc.20053—
+1K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc.20042092
+1K033801Kyphx HV-R, Model C01AKyphon, Inc.20042122
+1K021499Cemvac Ultra Pre-Packed with Depuy 1 Bone CementDePuy Orthopaedics, Inc.20022—
+2K192403VK100 Percutaneous Vertebral Augmentation SystemBonwrx, Ltd.20190—
+2K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+2K122175Mendec Spine HV, Mendec Spine HV SystemTecres S.P.A.20131—
+2K102397Kyphon Xpede Bone CementMedtronic2011165—
+2K093828Kyph X HV-R Bone CementMedtronic, Inc.2010167—
+2K071927Modification to Vertebroplastic Radiopaque Bone CementDepuy Spine, A Johnson & Johnson Company20072—
+2K053336Staxx FX SystemSpine Wave, Inc.200612—
+2K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd.20061768
+2K043593Spine-Fix Biomimetic Bone CementTeknimed, S.A.200622—
+2K053445Smartmix Cemvac Pre-Filled with Smartset HV Bone CementDePuy Orthopaedics, Inc.20060—
+2K042691Vertefix Vertebroplasty Procedure SetCook, Inc.2005189—
+2K042415Mendec SpineTecres S.P.A.200528—
+2K042168CONCORD Radiopaque Bone CementGlobus Medical, Inc.20056—
+2K042591Smartmix Pre-Filled Mixing SystemDePuy Orthopaedics, Inc.20041—
+3K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed, Ltd.20242—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+3K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+3K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+3K181262SpineJack Expansion KitVexim SA20184—
+3K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+3K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+3K162618CONCORD Plus Radiopaque Bone CementGlobus Medical, Inc.20175—
+3K151227KYPHON XPEDE Bone CementMedtronic201554—
+3K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc.2015162—
+3K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+3K112907Confidence High Viscosity Spinal Cement, 16G / 20GMedos International SARL20110—
+3K103816Cohesion Bone CementTeknimed Sas20110—
+3K103433F20Teknimed, S.A.201118—
+3K080108Cortoss Bone Augmentation MaterialOrthovita, Inc.200904
+3K080873Opacity + Bone CementTeknimed, S.A.200820—
+3K071375Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)Disc-O-Tech Medical Technologies, Ltd.20070—
+3K070527Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek20071—
+3K063606Modification to Staxx FX SystemSpine Wave, Inc.200711—
+3K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek200717—
+3K063438VspspnTecres S.P.A.20070—
+3K063067Confidence Fenestrated Introducer NeedleDisc-O-Tech Medical Technologies, Ltd.20064—
+3K062452Kit Mendec Spine and Delivery SystemTecres S.P.A.200618—
+3K062424Confidence EX High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd.20067—
+3K061531Space Cpsxl Bone CementDfine, Inc.20062—
+4K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+4K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed, Ltd.20260—
+4K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed, Ltd.20250—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K240084V-STRUT® Vertebral ImplantHyprevention20240—
+4K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K202393SpineJack Expansion KitStryker Corporation20203—
+4K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+4K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K163032Kyphon Xpede Bone CementMedtronic, Inc.201752—
+4K160983Kyphon HV-R Bone CementMedtronic, Inc.201652—
+4K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+4K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC20130—
+4K113452Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc.20120—
+4K072133Avaflex Vertebral Augmentation NeedleCardinal Health, Inc.20073—
+4K072496Modification to Space Cpsxl Bone CementDfine, Inc.20071—
+4K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.200710—
+4K070351Space 360 Delivery SystemDfine, Inc.20071—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+5K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+5K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+5K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+5K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+5K180700KYPHON HV-R Bone CementMedtronic Sofamor Danek USA, Inc.201851—
+5K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+5K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+5K100479Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20101—
+5K090986Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/…Dfine, Inc.20090—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—