510(k) Report

Devices descending from K001941

800 later devices reach Synthes Modular Foot System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K142836Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc.20145—
+1K133536Emerge Medical Bone Plate SystemEmerge Medical20140—
+1K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical20140—
+1K1133642.7MM LCP Ulna Osteotomy SystemSynthes (USA) Products, LLC201231
+1K103705Low Profile ScrewsArthrex, Inc.2011219—
+1K091493Ortho Select Bone Plates and Screw SystemOrtho Select Implant Technology Gesellschaft20100—
+1K060474Lisfranc PlateNew Deal, S.A.20061—
+1K060476Lapidus PlateNew Deal, S.A.20061—
+1K052152B-Bop PlateNew Deal, S.A.20051—
+1K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592—
+1K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004249—
+1K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC20049810
+1K021626Hallu PlatesNew Deal, S.A.2002280—
+1K012655Congruent Bone Plate SystemAcu Med, Inc.200179216
+2K252061Distal Xtremities SystemTriMed, Inc.20250—
+2K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+2K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+2K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+2K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.20240—
+2K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+2K233311Acumed Wrist Plating SystemAcumed, LLC20243—
+2K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+2K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+2K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+2K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+2K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+2K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+2K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+2K143331Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc.20154—
+2K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+2K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+2K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+2K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+2K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+2K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+2K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+2K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+2K131834Wolf Long Bone Plate SystemToby Orthopaedics20130—
+2K131636Polarus ConnectAcumed, LLC20130—
+2K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+2K130510Arthrex Compression PlatesArthrex, Inc.20138—
+2K131061Restore Bunion Correction SystemNextremity Solutions201315—
+2K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+2K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+2K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+2K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+2K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+2K112437Arthrex Fracture SystemArthrex, Inc.201191—
+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—
+2K111266Easylock OsteosystemTriMed, Inc.20110—
+2K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+2K102998Congruent Bone Plate SystemAcumed, LLC201191—
+2K100944Clavicle Locking Plate SystemNewclip Technics20109—
+2K093781Modified: Newdeal Hallu PlatesNewdeal Sas20101—
+2K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+2K083154Newdeal Hallu Lock Plate SystemNewdeal Sas200921
+2K080184Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2008151
+2K073375Newdeal Tibiaxys SystemNewdeal Sas2008732
+2K071715Acumed Congruent Bone Plate SystemAcumed, LLC200734—
+2K063820Lisfranc PlateNew Deal, S.A.20070—
+2K070241Modification to Lapidus PlateNew Deal, S.A.200701
+2K063831Basal Dorsal PlatesNewdeal Sas20070—
+2K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+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
+2K052614Low Profile Plate and Screw SystemArthrex, Inc.2005245—
+2K051410Acumed Rib Congrient Bone Plate SystemAcumed, LLC200591
+2K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+2K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+2K050852Claviculaplate with Angular Stablity Bone Plate SystemI.T.S. Implantat-Technologie-Systeme GmbH2005381
+2K051083Acumed Scapula Congruent Bone Plate SystemAcumed, LLC20052—
+2K021321Wrist Fusion PlateAcu Med, Inc.2002113—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K254215Arthrex Beaming SystemArthrex, Inc.20261—
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+3K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+3K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC202511
+3K242988Genostis Osteosynthesis SystemGenostis AF20250—