510(k) Report

Devices descending from K033805

142 later devices reach Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+1K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+1K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+1K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+1K103332Aptus Ulna PlatesMedartis AG201171—
+1K042598Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc.2004311
+2K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+2K260069DePuy Synthes VOLT™ Proximal Tibia 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—
+2K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+2K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+2K232144Sterile Products of the APTUS SystemMedartis AG20233—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+2K200062Foot and Ankle SystemLeith Medical, LLC20210—
+2K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+2K201656ARIX Elbow SystemJeil Medical Corporation20200—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+2K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+2K151468ARIX Wrist SystemJeil Medical Corporation20167—
+2K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+2K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+2K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+2K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+2K141734Zimmer Periarticular Locking SystemZimmer, Inc.201403
+2K141232Aptus Ulna Shortening 2.5Medartis AG201451
+2K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+2K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+2K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+2K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+2K111447Zimmer Periarticular ScrewsZimmer, Inc.201114
+2K111039Zimmer Periarticular Locking Plate SystemZimmer, Inc.201134
+2K050121Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc.200527—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+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—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+3K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+3K221395Footmotion Plating SystemNewclip Technics20220—
+3K213214Xpert WristNewclip Technics20210—
+3K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+3K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K173641Activ AnkleNewclip Technics20183—
+3K172008ARIX Humerus SystemJeil Medical Corporation20173—
+3K170705ARIX Wrist SystemJeil Medical Corporation20172—
+3K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+3K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K161861APTUS® Coronoid 2.0Medartis AG20170—
+3K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+3K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+3K142579Zimmer Periarticular Plating SystemZimmer, Inc.201402
+3K070906Modificaton to: Zimmer Periarticular Locking Plates and ScrewsZimmer, Inc.20071421
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K261511Xpert AnkleNewclip Technics20260—
+4K261191Alians Elbow SNewclip Technics20260—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+4K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+4K230938ARIX Humerus SystemJeil Medical Corporation20230—
+4K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K191009Arsenal Plating SystemTrilliant Surgical20192—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—