510(k) Report

Devices descending from K120854

44 later devices reach Synthes VA LCP Ankle Trauma System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+1K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+1K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+1K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+1K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+1K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+1K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+2K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+2K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+2K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+2K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+2K221395Footmotion Plating SystemNewclip Technics20220—
+2K213214Xpert WristNewclip Technics20210—
+2K200062Foot and Ankle SystemLeith Medical, LLC20210—
+2K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+2K173641Activ AnkleNewclip Technics20183—
+2K170843Alians Fragment SpecificNewclip Technics20171—
+2K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+2K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+2K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+3K261511Xpert AnkleNewclip Technics20260—
+3K261191Alians Elbow SNewclip Technics20260—
+3K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+3K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+3K191009Arsenal Plating SystemTrilliant Surgical20192—
+3K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+3K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+4K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—