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
+2K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+2K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006108—
+2K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+2K060041Trimed Bone PlatesTriMed, Inc.2006263
+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—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+3K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K241539Activmotion SNewclip Technics20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+3K213214Xpert WristNewclip Technics20210—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+3K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+3K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+3K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+3K172350AxSOS 3 TiStryker GmbH201717—
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+3K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+3K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+3K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+3K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+3K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+3K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+3K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+3K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K150675Dorsal Spanning PlateSkeletal Dynamics, LLC20151—
+3K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+3K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+3K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+3K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+3K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+3K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+3K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+3K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+3K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+3K110271Maestro Wrist Plating SystemBiomet Manufacturing Corp20110—
+3K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+3K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+3K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+3K100944Clavicle Locking Plate SystemNewclip Technics20109—
+3K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+3K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+3K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+3K091156Trimed Sterile ProductTriMed, Inc.20090—
+3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+3K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+4K262649Alians ForearmNewclip Technics20260—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+4K250155Xpert KneeNewclip Technics20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—