510(k) Report

Devices descending from K000682

340 later devices reach Synthes Large Fragment Dynamic Compression Locking (DCL) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+1K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K161894SurgTech Trauma SystemSurgtech, Inc.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—
+1K141796Depuy Synthes Tomofix Osteotomy SystemSynthes (USA) Products, LLC201414—
+1K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical20141—
+1K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+1K113648Loqteq Large Fragment Set Loqteq Cortical Screw 4.5, Small Head, T25, Self Tapping…Aap Implantate AG20121—
+1K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+1K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+1K1105923.7MM/5.0MM Dynamic Locking ScrewSynthes USA201102
+1K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+1K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSynthes (Usa)2008186—
+1K0724234.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous…DePuy Orthopaedics, Inc.20074—
+1K012623Reprocessed External Fixation DeviceAlliance Medical Corp.20021—
+2K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+2K260090SMART Osteotomy SystemActis Medical Pty., Ltd.20260—
+2K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+2K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+2K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+2K250155Xpert KneeNewclip Technics20250—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+2K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+2K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+2K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+2K241356Fine Osteotomy™Bodycad Laboratories, Inc.20243—
+2K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+2K241539Activmotion SNewclip Technics20240—
+2K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+2K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+2K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+2K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+2K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+2K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+2K213108Humerus & Ulna SystemAuxein Medical Private Limited20221—
+2K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+2K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+2K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K200062Foot and Ankle SystemLeith Medical, LLC20210—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+2K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K173746Activmotion RangeNewclip Technics20181—
+2K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+2K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K162507Arzzt 3.5 / 4.5 Small & Large Fragments SystemTruemed Group, LLC20173—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+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—
+2K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+2K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+2K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+2K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+2K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+2K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+2K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+2K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+2K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+2K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+2K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+2K141949Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping…Aap Implantate AG20140—
+2K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+2K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+2K140607Aap Loqtec (R) Olecranon PlateAap Implantate AG20141—
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical20140—
+2K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+2K131834Wolf Long Bone Plate SystemToby Orthopaedics20130—
+2K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+2K131764Acumed Wrist Spanning PlateAcumed, LLC20137—