510(k) Report

Devices descending from K082807

186 later devices reach Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+1K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+1K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+1K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+1K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+1K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+1K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+1K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+1K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+1K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+1K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+1K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+1K213108Humerus & Ulna SystemAuxein Medical Private Limited20221—
+1K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+1K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+1K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+1K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+1K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+1K162507Arzzt 3.5 / 4.5 Small & Large Fragments SystemTruemed Group, LLC20173—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+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—
+1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+1K140607Aap Loqtec (R) Olecranon PlateAap Implantate AG20141—
+1K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical20141—
+1K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical20140—
+1K131834Wolf Long Bone Plate SystemToby Orthopaedics20130—
+1K131764Acumed Wrist Spanning PlateAcumed, LLC20137—
+1K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+1K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+1K130009Variax 2 Compression Plating SystemStryker Trauma AG2013271
+1K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+1K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc.20135—
+1K113718NCB Straight Narrow Shaft PlatesZimmer GmbH201271
+1K112926Axsos Locking Plate SystemStryker Corp.20110—
+1K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+1K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc.2010182
+1K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+1K092609Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Synthes (Usa)200951—
+2K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+2K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+2K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+2K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+2K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+2K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC202511
+2K243469SignexOsteonic Co., Ltd.20250—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+2K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.20240—
+2K241942TriMed Bridge PlatesTriMed, Inc.20240—
+2K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH20240—
+2K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+2K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+2K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+2K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+2K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+2K213214Xpert WristNewclip Technics20210—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+2K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+2K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC20191—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180—
+2K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K160995NEOVIEW Plating SystemIn2bones Sas201624
+2K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+2K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+2K152000SMV Scientific Bone Plate and Screw SystemSmv Scientific20153—
+2K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+2K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+2K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+2K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+2K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+2K140565Variax 2 Compression Plating SystemStryker Trauma AG20143—
+2K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+2K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+2K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+2K132502Variax 2 SystemStryker Trauma AG201321—
+2K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+2K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+2K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130—
+2K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+2K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH201262
+2K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+2K112085Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC20114—
+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—
+3K261038Xpert PFPNewclip Technics20260—