510(k) Report

Devices descending from K120070

76 later devices reach Synthes Variable Angle LCP Elbow System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+1K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+1K243469SignexOsteonic Co., Ltd.20250—
+1K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+1K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+1K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+1K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+1K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+1K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+1K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+1K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+1K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+2K261191Alians Elbow SNewclip Technics20260—
+2K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+2K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+2K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+2K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+2K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+2K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+2K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+2K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+2K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+2K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+2K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K173641Activ AnkleNewclip Technics20183—
+2K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+2K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+2K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+2K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+2K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K261511Xpert AnkleNewclip Technics20260—
+3K260761APTUS Clavicle System 2.8Medartis AG20260—
+3K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+3K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K221395Footmotion Plating SystemNewclip Technics20220—
+3K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+3K213214Xpert WristNewclip Technics20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+3K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+4K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+4K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+4K191009Arsenal Plating SystemTrilliant Surgical20192—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—