510(k) Report

Devices descending from K060613

341 later devices reach Variax Locking Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+5K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+5K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+5K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+5K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+5K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230204ALPHALOK Plating SystemVilex, LLC20230—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+5K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+5K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+5K221558ALPHALOK Plating SystemVilex, LLC20222—
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+5K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+5K211843PolyLock Plating SystemFusion Orthopedics20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+5K213214Xpert WristNewclip Technics20210—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+5K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200226RetroFixRetrofix Screws, LLC20200—
+5K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+5K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K191867ATLAS Plating SystemMiRus, LLC20200—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+5K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190830TDM Screw SystemsTdm Co., Ltd.20191—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K181091AxSOS 3 TiStryker GmbH201811—
+5K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K173641Activ AnkleNewclip Technics20183—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+5K170771VariAx 2 Foot SystemStryker GmbH20170—
+5K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+5K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+5K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+5K151769Anchorage 2 CP SystemStryker GmbH20150—
+5K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+5K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+5K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+5K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+5K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K262344Large Compression ScrewsTriMed, Inc.20260—
+6K261511Xpert AnkleNewclip Technics20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260761APTUS Clavicle System 2.8Medartis AG20260—
+6K261241TriMed Compression ScrewsTriMed, Inc.20260—
+6K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+6K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+6K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+6K231860TDM Screw SystemTdm Co., Ltd.20240—
+6K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—