510(k) Report

Devices descending from K792022

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+3K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+3K143146Nexis osteosynthesis snap-off screwsNovastep20152—
+3K143229Nexis osteosynthesis compressive screwsNovastep20153—
+3K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+3K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+3K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+3K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140—
+3K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp2014362
+3K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+3K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+3K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+3K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+3K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K131311Arix Foot SystemJeil Medical Corporation20139—
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+3K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+3K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+3K124027Monster Screw SystemApogee Orthosolutions201341—
+3K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+3K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+3K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+3K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+3K102528N-Force Fixation SystemInnovision, Inc.20115—
+3K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+3K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+3K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+3K081934Extremity Medical Compression ScrewExtremity Medical, LLC200868—
+3K052624Inion Otps Biodegradable Distal Radius PlateInion, Ltd.20050—
+3K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+3K043145BI-Cortical Bio-Post and Washer, Model AR-1367BArthrex, Inc.200501
+3K042295Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020Linvatec Biomaterials, Ltd.20041—
+3K040356Kompressor Screw SystemKinetikos Medical, Inc.2004255—
+3K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd.2003333—
+3K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+3K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K262075Lapidus Screw KitRelja Innovations, LLC20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+4K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K223468Nexis® compressive screwsNovastep20230—
+4K230397Cut Screw - Percutaneous Compression ScrewGM Dos Reis Industria e Comercio Ltda.20230—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K220921Metal Bone ScrewDouble Medical Technology, Inc.20221—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+4K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+4K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+4K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+4K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+4K190830TDM Screw SystemsTdm Co., Ltd.20191—
+4K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+4K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K182677DynaNail MiniMedShape, Inc.20195—
+4K190035Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc.20194—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K182989AURORA™ Screw SystemMiRus, LLC20180—
+4K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+4K170697GBR systemSurgident20182—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—