510(k) Report

Devices descending from K021626

280 later devices reach Hallu Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+6K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+6K254182AsterOsteonic Co., Ltd.20260—
+6K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+6K243469SignexOsteonic Co., Ltd.20250—
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+6K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+6K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+6K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+6K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K210159IntraLock SystemFusion Orthopedics, LLC20210—
+6K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+6K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+6K202307Activ FuseNewclip Technics20200—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+6K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+6K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+6K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+6K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+6K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+6K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K173746Activmotion RangeNewclip Technics20181—
+6K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+7K254280F.A.S.T ScrewSteps Ortho20260—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+7K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+7K252246Leforte MMF SystemJeil Medical Corporation20260—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+7K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+7K240487EVOS Patella PlatesSmith & Nephew20240—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K241539Activmotion SNewclip Technics20240—
+7K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+7K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+7K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+7K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+8K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+9K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+9K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—