510(k) Report

Devices descending from K083025

68 later devices reach Synthes 4.5 MM VA-LCP Curved Condylar System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+1K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical20141—
+1K1103544.5MM VA-LCP Curved Condylar Plate SystemSynthes USA2011622
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+2K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+2K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+2K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+2K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+2K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+3K253906Xpert HandNewclip Technics20260—
+3K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+3K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+3K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+3K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20182—
+3K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+3K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K213214Xpert WristNewclip Technics20210—
+4K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+4K173641Activ AnkleNewclip Technics20183—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+5K261511Xpert AnkleNewclip Technics20260—
+5K261191Alians Elbow SNewclip Technics20260—
+5K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K191009Arsenal Plating SystemTrilliant Surgical20192—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+6K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—