510(k) Report

Devices descending from K012655

792 later devices reach Congruent Bone Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.20240—
+1K233311Acumed Wrist Plating SystemAcumed, LLC20243—
+1K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+1K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+1K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+1K131834Wolf Long Bone Plate SystemToby Orthopaedics20130—
+1K131636Polarus ConnectAcumed, LLC20130—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+1K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+1K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—
+1K103513Lateral Superior Clavicle Plate, Left and Right; Midshaft Superior Clavicle Plate, Left…Advanced Orthopaedic Solutions, Inc.20111—
+1K102998Congruent Bone Plate SystemAcumed, LLC201191—
+1K100944Clavicle Locking Plate SystemNewclip Technics20109—
+1K080184Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2008151
+1K071715Acumed Congruent Bone Plate SystemAcumed, LLC200734—
+1K063095Humerus Locking Plating SystemNewclip Technics20064—
+1K063460Acumed Congruent Bone Plate SystemAcumed, LLC200621—
+1K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+1K052368Olecranonplate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH200551
+1K052152B-Bop PlateNew Deal, S.A.20051—
+1K051410Acumed Rib Congrient Bone Plate SystemAcumed, LLC200591
+1K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+1K050852Claviculaplate with Angular Stablity Bone Plate SystemI.T.S. Implantat-Technologie-Systeme GmbH2005381
+1K051083Acumed Scapula Congruent Bone Plate SystemAcumed, LLC20052—
+1K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004249—
+1K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC20049810
+1K021626Hallu PlatesNew Deal, S.A.2002280—
+1K021321Wrist Fusion PlateAcu Med, Inc.2002113—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+2K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC202511
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K243275Equinoxe® Scapula Fracture SystemExactech, Inc.20250—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K230805TriMed Clavicle Fixation SystemTriMed, Inc.20230—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+2K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K200538Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc.20201—
+2K192984APTUS Clavicle SystemMedartis AG20206—
+2K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+2K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+2K170310Alians Clavicle rangeNewclip Technics20170—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K161861APTUS® Coronoid 2.0Medartis AG20170—
+2K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+2K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+2K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+2K141548High Tibial Osteotomy SystemNewclip Technics20153—
+2K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+2K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+2K130510Arthrex Compression PlatesArthrex, Inc.20138—
+2K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+2K130774Universal Distal Radius SystemNewclip Technics20135—
+2K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K122623Short Lateral Superior Clavicle Plate, Left and Right Model 3017-000 (Left) and 3018-000…Advanced Orthopaedic Solutions, Inc.20120—
+2K120903Congruent Bone Plate System: Acu-Loc 2 PlateAcumed, LLC20126—
+2K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+2K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+2K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+2K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC201281
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—
+2K1032432.4MM VA-LCP Intercarpal Fusion SystemSynthes (Usa)2011187
+2K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+2K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+2K093781Modified: Newdeal Hallu PlatesNewdeal Sas20101—
+2K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+2K083154Newdeal Hallu Lock Plate SystemNewdeal Sas200921
+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—
+2K073375Newdeal Tibiaxys SystemNewdeal Sas2008732
+2K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+2K063831Basal Dorsal PlatesNewdeal Sas20070—
+2K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+2K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+2K060474Lisfranc PlateNew Deal, S.A.20061—
+2K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006108—
+2K060476Lapidus PlateNew Deal, S.A.20061—
+2K060041Trimed Bone PlatesTriMed, Inc.2006263
+2K052614Low Profile Plate and Screw SystemArthrex, Inc.2005245—
+2K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592—
+2K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+2K030881Avanta Carpal Fusion Plating SystemAvanta Orthopaedics, Inc.20030—
+3K260761APTUS Clavicle System 2.8Medartis AG20260—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—