510(k) Report

Devices descending from K041860

654 later devices reach Synthes (Usa) LCP Proximal Humerus Plates, Long through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+1K243469SignexOsteonic Co., Ltd.20250—
+1K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+1K233994VOLT™ Proximal Humerus 3.5 Plating SystemSynthes GmbH20240—
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+1K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+1K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+1K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+1K211582LOQTEQ Proximal Humerus Plate 3.5 SystemAap Implantate AG20211—
+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—
+1K181587ORTHOLOC SPS Shoulder Plating SystemTornier, Inc.20181—
+1K181425APTUS® Proximal Humerus SystemMedartis AG20181—
+1K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos)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—
+1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+1K143138AxSOS 3 Ti Locking Plate SystemStryker Trauma AG201426—
+1K133452Emerge Medical Small Fragment Locked Plating SystemEmerge Medical20140—
+1K130108Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd.20139—
+1K121495Loqteq Proximal Humerus Plate 3.5, Short Loqteq Proximal Humerus Plate 3.5, LongAap Implantate AG20122—
+1K121672Aft Proximal Humerus Fracture PlateShoulder Options, Inc.201220—
+1K120108Aptus Proximal Humerus SystemMedartis AG20122—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+1K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa)2011172
+1K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+1K093978Exactech Equinoxe Proximal Humerus Fracture Plate SystemExactech, Inc.20104—
+1K063095Humerus Locking Plating SystemNewclip Technics20064—
+1K062494Ebi Optilock Upper Extremity Plating SystemEbi, L.P.2006221
+1K060545Unity Humeral PlateTornier20060—
+1K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+1K051412Humeral Head Plate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH200521
+2K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+2K254253LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AG20260—
+2K252016Arthrex Humeral NailsArthrex, Inc.20260—
+2K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+2K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+2K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.20250—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+2K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+2K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+2K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+2K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K221088Anatomic Bone PlateDouble Medical Technology, Inc.20231—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+2K220921Metal Bone ScrewDouble Medical Technology, Inc.20221—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K191711ORTHOLOC™ SPS Shoulder Plating SystemTornier, Inc.20190—
+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—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K160995NEOVIEW Plating SystemIn2bones Sas201624
+2K153379AxSOS 3TiStryker GmbH201625—
+2K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+2K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+2K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+2K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+2K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+2K141548High Tibial Osteotomy SystemNewclip Technics20153—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+2K133668Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate…Shoulder Options, Inc.201416—
+2K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+2K131636Polarus ConnectAcumed, LLC20130—
+2K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+2K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC201215—
+2K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+2K110201Explor Radial Head Plating SystemBiomet, Inc.20110—
+2K110320Comprehensiveproximal Humeral Plating SystemBiomet Manufacturing Corp20110—
+2K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+2K093761Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp)20103—
+2K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+2K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+2K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+2K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.200887—
+2K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—