510(k) Report

Devices descending from K792022

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+6K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+6K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+6K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+6K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+6K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+6K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+6K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+6K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+6K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+6K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+6K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+6K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+6K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+6K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+6K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+6K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+6K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+6K220650TriMed Ripcord DeviceTriMed, Inc.202211
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+6K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+6K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+6K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+6K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K212552Correx SoftwareVilex, LLC20210—
+6K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+6K211435PAO Cortical ScrewMedacta International S.A.20210—
+6K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+6K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+6K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+6K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+6K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+6K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+6K202307Activ FuseNewclip Technics20200—
+6K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+6K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+6K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+6K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+6K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+6K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+6K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+6K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+6K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+6K191636APTUS Foot SystemMedartis AG20190—
+6K191241AutoStrutOrthospin20194—
+6K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+6K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+6K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+6K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+6K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+6K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+6K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+6K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+6K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+6K173883External Fixation SystemLife Spine, Inc.20180—
+6K180759SECULOK™ Suture AnchorU&I Corporation20180—
+6K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+6K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+6K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+6K173746Activmotion RangeNewclip Technics20181—
+6K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+6K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—