510(k) Report

Devices descending from K022325

521 later devices reach Normed Titanium Osteotomy Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+5K172350AxSOS 3 TiStryker GmbH201717—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K162171S4 Screw System™Subchondral Solutions20173—
+5K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+5K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+5K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+5K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+5K170771VariAx 2 Foot SystemStryker GmbH20170—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+5K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+5K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+5K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+5K151769Anchorage 2 CP SystemStryker GmbH20150—
+5K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+5K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+5K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+5K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+5K150009BaideJiangsu Baide Medical Intrument Co., Ltd.20151—
+5K143139Arthrex Fracture SystemArthrex, Inc.20151—
+5K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+5K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+5K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd.20142—
+5K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+5K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+5K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+5K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+5K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+5K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+6K262975Arthrex Beaming SystemArthrex, Inc.20260—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K262344Large Compression ScrewsTriMed, Inc.20260—
+6K261511Xpert AnkleNewclip Technics20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K261241TriMed Compression ScrewsTriMed, Inc.20260—
+6K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K254182AsterOsteonic Co., Ltd.20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+6K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.20250—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+6K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+6K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+6K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K231860TDM Screw SystemTdm Co., Ltd.20240—
+6K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+6K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+6K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+6K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+6K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+6K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+6K210159IntraLock SystemFusion Orthopedics, LLC20210—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+6K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+6K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+6K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+6K202307Activ FuseNewclip Technics20200—
+6K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+6K191867ATLAS Plating SystemMiRus, LLC20200—
+6K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+6K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+6K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+6K181091AxSOS 3 TiStryker GmbH201811—
+6K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+6K173746Activmotion RangeNewclip Technics20181—
+6K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+6K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+6K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+6K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+6K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+6K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+7K254280F.A.S.T ScrewSteps Ortho20260—
+7K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—