510(k) Report

Devices descending from K091614

156 later devices reach Osteomed Foot Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143365Eminent Foot Plate SystemEminent Spine20151—
+1K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+1K140283Osteomed Extremifuse SystemOsteomed20140—
+1K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+1K131445Osteomed Extremilock Foot Plating SystemOsteomed LP20138—
+1K130412Osteomed Extremifuse SystemOsteomed20134—
+1K130964Gridlock Plating SystemTrilliant Surgical, Ltd.201331
+1K123525Gridlock Plating SystemTrilliant Surgical, Ltd.201341
+1K123000Integra Total Foot SystemsIntegra LifeSciences Corporation201254—
+1K121452Gridlock Plating SystemTrilliant Surgical, Ltd.2012114
+1K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+1K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+1K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+2K251709MedCAD® AccuStride™ SystemMedcad20250—
+2K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+2K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+2K191009Arsenal Plating SystemTrilliant Surgical20192—
+2K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+2K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K172886Breakaway Screw SystemParagon 2820174—
+2K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+2K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+2K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+2K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+2K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+2K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K163293Colink™ Plating SystemIn2bones USA, LLC2017212
+2K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+2K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+2K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+2K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+2K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+2K133515Peek Fusion ImplantMtp Solutions, LLC20142—
+2K132594Crosscheck Plating SystemSolana Surgical, LLC20132321
+2K1334371ST MTP PlateOsteomed20132—
+2K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+2K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+3K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+3K221395Footmotion Plating SystemNewclip Technics20220—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+3K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+3K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+3K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+3K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+3K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+3K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+3K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+3K161448Footmotion Plating SystemNewclip Technics20165—
+3K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+3K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+3K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+3K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+3K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+3K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+3K140970One-Piece Peek Fusion ImplantMtp Solutions, LLC20140—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K252246Leforte MMF SystemJeil Medical Corporation20260—
+4K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—