510(k) Report

Devices descending from K021626

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+4K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate SystemGraham Medical Technologies, LLC Dba Gramedica20170—
+4K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K143721PRCT2Fx Solutions20150—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+4K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+4K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+4K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+4K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+4K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+4K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+4K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+4K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+4K112437Arthrex Fracture SystemArthrex, Inc.201191—
+4K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K254215Arthrex Beaming SystemArthrex, Inc.20261—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+5K230546SignexOsteonic Co., Ltd.20242—
+5K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+5K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+5K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+5K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+5K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+5K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200226RetroFixRetrofix Screws, LLC20200—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+5K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+5K162171S4 Screw System™Subchondral Solutions20173—
+5K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+5K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+5K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+5K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+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—
+5K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+5K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+5K143139Arthrex Fracture SystemArthrex, Inc.20151—
+5K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+5K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+5K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+6K262975Arthrex Beaming SystemArthrex, Inc.20260—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K261511Xpert AnkleNewclip Technics20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260761APTUS Clavicle System 2.8Medartis AG20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—