510(k) Report

Devices descending from K062564

150 later devices reach Synthes LCP Distal Femur Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261038Xpert PFPNewclip Technics20260—
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K243469SignexOsteonic Co., Ltd.20250—
+1K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+1K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+1K210043LOQTEQ Distal Lateral Femur Plate 4.5 SystemAap Implantate AG20211—
+1K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+1K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd.201811—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+1K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+1K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+1K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+1K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+1K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical20141—
+1K123964Axsos 3 TI Locking Plate SystemStryker Trauma AG201319—
+1K121494Loqteq Distal Lateral Femur Plate 4.5 (Left and Right Version) Loqreq Cortical Screw 4.5…Aap Implantate AG20122—
+1K111891Synthes Brainlab Trauma Compatible InstrumentsSynthes (USA) Products, LLC20110—
+1K1103544.5MM VA-LCP Curved Condylar Plate SystemSynthes USA2011622
+1K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+2K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+2K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+2K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+2K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+2K230690Tandry Locking Plate SystemMicroware Precision Co., Ltd.20231—
+2K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+2K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+2K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+2K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+2K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20212—
+2K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+2K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+2K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+2K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+2K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+2K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+2K133440Axsos 3 TI Locking Plate System Line ExtensionStryker Trauma AG201312—
+2K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+2K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+2K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+2K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+2K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+2K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+2K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+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—
+3K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+3K253906Xpert HandNewclip Technics20260—
+3K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K250155Xpert KneeNewclip Technics20250—
+3K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+3K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+3K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+3K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+3K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+3K213572JuniOrtho Plating System™Orthofix Srl20220—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+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—
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+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—
+3K173746Activmotion RangeNewclip Technics20181—
+3K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+3K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, 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—
+3K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+3K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+4K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—