510(k) Report

Devices descending from K011334

798 later devices reach Synthes Curved Reconstruction Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+3K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+3K093781Modified: Newdeal Hallu PlatesNewdeal Sas20101—
+3K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+3K083154Newdeal Hallu Lock Plate SystemNewdeal Sas200921
+3K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+3K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+3K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.200887—
+3K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+3K073375Newdeal Tibiaxys SystemNewdeal Sas2008732
+3K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+3K063831Basal Dorsal PlatesNewdeal Sas20070—
+3K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+3K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+3K060474Lisfranc PlateNew Deal, S.A.20061—
+3K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006108—
+3K060476Lapidus PlateNew Deal, S.A.20061—
+3K060041Trimed Bone PlatesTriMed, Inc.2006263
+3K052614Low Profile Plate and Screw SystemArthrex, Inc.2005245—
+3K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592—
+3K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+3K030881Avanta Carpal Fusion Plating SystemAvanta Orthopaedics, Inc.20030—
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—
+4K252061Distal Xtremities SystemTriMed, Inc.20250—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+4K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+4K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+4K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+4K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical20240—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K230546SignexOsteonic Co., Ltd.20242—
+4K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+4K221412ARIX Rib SystemJeil Medical Corporation20221—
+4K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+4K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K202803Activmotion S DTONewclip Technics20210—
+4K213214Xpert WristNewclip Technics20210—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+4K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+4K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+4K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+4K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+4K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+4K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+4K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K170972Apex Tibial Nailing SystemOrthoxel20171—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+4K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+4K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+4K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+4K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—