510(k) Report

Devices descending from K792022

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+6K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+6K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+6K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+6K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+6K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+6K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+6K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+6K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+6K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+6K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+6K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+6K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+6K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+6K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+6K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+6K143092Tensyn PlugDallen Medical, Inc.20151—
+6K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+6K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+6K143139Arthrex Fracture SystemArthrex, Inc.20151—
+6K141420FastforwardMedShape, Inc.20145—
+6K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+6K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+6K141992Variax 2 SystemStryker Trauma AG201422—
+6K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+6K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+6K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+6K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+6K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+6K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+6K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+6K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+6K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+6K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+6K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+6K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+6K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+6K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+6K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+6K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+6K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+6K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+6K090107Mini TightropeArthrex, Inc.200921—
+6K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+6K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+6K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+6K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+6K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K261191Alians Elbow SNewclip Technics20260—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+7K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+7K253115Lars AcjMovmedix S.A.S.20260—
+7K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K251134RipCordTriMed, Inc.20250—
+7K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+7K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+7K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+7K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+7K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+7K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+7K242091Bolo Button SystemFusion Orthopedics20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+7K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+7K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+7K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+7K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241539Activmotion SNewclip Technics20240—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K230546SignexOsteonic Co., Ltd.20242—
+7K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+7K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+7K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+7K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+7K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+7K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—