510(k) Report

Devices descending from K011335

840 later devices reach Synths One-Third Tubular DCL Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+2K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K173641Activ AnkleNewclip Technics20183—
+2K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+2K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+2K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+2K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+2K172008ARIX Humerus SystemJeil Medical Corporation20173—
+2K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ®…Aap Implantate AG20160—
+2K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, WasherAap Implantate AG20160—
+2K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+2K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+2K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+2K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+2K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+2K151879VariAx 2 One-Third Tubular Plating SystemStryker GmbH20156—
+2K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+2K150675Dorsal Spanning PlateSkeletal Dynamics, LLC20151—
+2K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+2K143139Arthrex Fracture SystemArthrex, Inc.20151—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+2K141949Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping…Aap Implantate AG20140—
+2K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+2K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+2K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+2K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+2K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical20140—
+2K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+2K132502Variax 2 SystemStryker Trauma AG201321—
+2K131636Polarus ConnectAcumed, LLC20130—
+2K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+2K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K123000Integra Total Foot SystemsIntegra LifeSciences Corporation201254—
+2K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+2K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+2K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+2K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—
+2K103513Lateral Superior Clavicle Plate, Left and Right; Midshaft Superior Clavicle Plate, Left…Advanced Orthopaedic Solutions, Inc.20111—
+2K110271Maestro Wrist Plating SystemBiomet Manufacturing Corp20110—
+2K102998Congruent Bone Plate SystemAcumed, LLC201191—
+2K100944Clavicle Locking Plate SystemNewclip Technics20109—
+2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+2K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+2K080184Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2008151
+2K071715Acumed Congruent Bone Plate SystemAcumed, LLC200734—
+2K063095Humerus Locking Plating SystemNewclip Technics20064—
+2K063460Acumed Congruent Bone Plate SystemAcumed, LLC200621—
+2K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+2K052368Olecranonplate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH200551
+2K052152B-Bop PlateNew Deal, S.A.20051—
+2K051410Acumed Rib Congrient Bone Plate SystemAcumed, LLC200591
+2K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+2K050852Claviculaplate with Angular Stablity Bone Plate SystemI.T.S. Implantat-Technologie-Systeme GmbH2005381
+2K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004249—
+2K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC20049810
+2K021626Hallu PlatesNew Deal, S.A.2002280—
+2K021321Wrist Fusion PlateAcu Med, Inc.2002113—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K261511Xpert AnkleNewclip Technics20260—
+3K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+3K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K254182AsterOsteonic Co., Ltd.20260—
+3K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC202511
+3K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+3K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+3K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+3K230805TriMed Clavicle Fixation SystemTriMed, Inc.20230—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—