510(k) Report

Devices descending from K033995

624 later devices reach 3.5 MM LCP Distal Humerus System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+1K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+1K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+1K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+1K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+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—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG20161—
+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—
+1K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+1K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+1K132787Loqteq Distal Dorsolateral Humerus PlateAap Implantate AG20131—
+1K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+1K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+1K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+1K091619Anglefix T Locking Plate, Models AF-001 (Plate), ST-1 (Locking Screw)Anglefix20090—
+1K080184Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2008151
+1K062494Ebi Optilock Upper Extremity Plating SystemEbi, L.P.2006221
+1K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+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—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+2K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+2K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+2K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+2K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+2K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+2K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+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—
+2K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+2K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+2K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+2K131636Polarus ConnectAcumed, LLC20130—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+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—
+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—
+3K261191Alians Elbow SNewclip Technics20260—
+3K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+3K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+3K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+3K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+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—
+3K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—