510(k) Report

Devices descending from K073460

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230623KITE Distal Fibula KitIntrauma S.P.A20230—
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+1K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc201713—
+1K152732AOS Small Fragment Plating SystemAvanced Orthopaedic Solutions, Inc. (Aos)20153—
+1K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+1K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+1K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+2K230204ALPHALOK Plating SystemVilex, LLC20230—
+2K221558ALPHALOK Plating SystemVilex, LLC20222—
+2K221395Footmotion Plating SystemNewclip Technics20220—
+2K213005Apollo Ankle Fracture Plating SystemGlw Medical, Inc.20221—
+2K213214Xpert WristNewclip Technics20210—
+2K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+2K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+2K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+2K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K173746Activmotion RangeNewclip Technics20181—
+2K173641Activ AnkleNewclip Technics20183—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K170843Alians Fragment SpecificNewclip Technics20171—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K161913AOS Small Fragment Plating SystemAdvanced Orthopaedic Solutions, Inc. (Aos)20162—
+2K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+2K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+2K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+2K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+2K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+2K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+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—
+3K261191Alians Elbow SNewclip Technics20260—
+3K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+3K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+3K241539Activmotion SNewclip Technics20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+3K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K181035AOS Small Fragment Plating System LiteAdvanced Orthopaedic Solutions, Inc. (Aos)20181—
+3K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+3K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+3K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+4K191009Arsenal Plating SystemTrilliant Surgical20192—
+4K182466AOS Calcaneal Plating SystemAdvanced Orthopaedic Solutions20180—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+5K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—