510(k) Report

Devices descending from K083213

80 later devices reach Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243469SignexOsteonic Co., Ltd.20250—
+1K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+1K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG202011—
+1K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+1K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+1K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+1K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+2K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+2K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+2K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+2K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+2K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+2K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+2K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+2K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+3K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K221395Footmotion Plating SystemNewclip Technics20220—
+3K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+3K213214Xpert WristNewclip Technics20210—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K191009Arsenal Plating SystemTrilliant Surgical20192—
+3K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+3K173641Activ AnkleNewclip Technics20183—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K261511Xpert AnkleNewclip Technics20260—
+4K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+4K261191Alians Elbow SNewclip Technics20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+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—
+4K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+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—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—