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
+3K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+3K213214Xpert WristNewclip Technics20210—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+3K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173641Activ AnkleNewclip Technics20183—
+3K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+3K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K172008ARIX Humerus SystemJeil Medical Corporation20173—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+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—
+3K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+3K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+3K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+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
+3K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+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—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K261511Xpert AnkleNewclip Technics20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+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—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K230938ARIX Humerus SystemJeil Medical Corporation20230—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K213572JuniOrtho Plating System™Orthofix Srl20220—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—