510(k) Report

Devices descending from K100618

339 later devices reach Maxlock Extreme Extremity Plating System with Variable Angle Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K230204ALPHALOK Plating SystemVilex, LLC20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+4K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K221558ALPHALOK Plating SystemVilex, LLC20222—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+4K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+4K211843PolyLock Plating SystemFusion Orthopedics20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+4K213214Xpert WristNewclip Technics20210—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+4K200961Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20209—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K191867ATLAS Plating SystemMiRus, LLC20200—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+4K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K190830TDM Screw SystemsTdm Co., Ltd.20191—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K181091AxSOS 3 TiStryker GmbH201811—
+4K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K173641Activ AnkleNewclip Technics20183—
+4K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+4K170771VariAx 2 Foot SystemStryker GmbH20170—
+4K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+4K151769Anchorage 2 CP SystemStryker GmbH20150—
+4K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+4K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+4K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201332—
+5K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+5K262344Large Compression ScrewsTriMed, Inc.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K261241TriMed Compression ScrewsTriMed, Inc.20260—
+5K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+5K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K231860TDM Screw SystemTdm Co., Ltd.20240—
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—