510(k) Report

Devices descending from K792022

988 later devices reach Herbert Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K231860TDM Screw SystemTdm Co., Ltd.20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+5K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+5K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+5K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+5K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203381Dynanail Mini HybridMedShape, Inc.202141
+5K203105Inion CompressOn ScrewInion OY20210—
+5K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+5K203011Monster Screw SystemParagon 28, Inc.20206—
+5K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K193368Smart Correction SystemWishbone Medical, Inc.202031
+5K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+5K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+5K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+5K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K193366T2 ICFStryker GmbH20201—
+5K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+5K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+5K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K173910Impress SFS SystemCable Fix Medical, LLC20180—
+5K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K171703PUMA SystemPanther Orthopedics, Inc.20180—
+5K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+5K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+5K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+5K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+5K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+5K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+5K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+5K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+5K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K160304OsteoBullet Compression ScrewPhalanx Innovations20168—
+5K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+5K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672