510(k) Report

Devices descending from K073624

342 later devices reach Modular Foot System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+4K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+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—
+4K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+4K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+4K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+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—
+4K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+4K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+4K173641Activ AnkleNewclip Technics20183—
+4K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+4K172350AxSOS 3 TiStryker GmbH201717—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K172178Minimally Invasive Bunion Plating SystemTrilliant Surgical, Ltd.20174—
+4K171510Footmotion Plating SystemNewclip Technics20171—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K170771VariAx 2 Foot SystemStryker GmbH20170—
+4K170012Foot and Hand MotionNewclip Technics20170—
+4K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+4K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+4K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+4K151769Anchorage 2 CP SystemStryker GmbH20150—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+4K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+5K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+5K262344Large Compression ScrewsTriMed, Inc.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+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—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+5K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+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—
+5K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240—
+5K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+5K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+5K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+5K231860TDM Screw SystemTdm Co., Ltd.20240—
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+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—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K211843PolyLock Plating SystemFusion Orthopedics20220—
+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—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—