510(k) Report

Devices descending from K011335

840 later devices reach Synths One-Third Tubular DCL Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+3K230938ARIX Humerus SystemJeil Medical Corporation20230—
+3K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+3K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+3K221395Footmotion Plating SystemNewclip Technics20220—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+3K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+3K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+3K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+3K213214Xpert WristNewclip Technics20210—
+3K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+3K202307Activ FuseNewclip Technics20200—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+3K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+3K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+3K200226RetroFixRetrofix Screws, LLC20200—
+3K200538Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc.20201—
+3K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K192984APTUS Clavicle SystemMedartis AG20206—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+3K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+3K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+3K191009Arsenal Plating SystemTrilliant Surgical20192—
+3K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+3K173746Activmotion RangeNewclip Technics20181—
+3K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K163293Colink™ Plating SystemIn2bones USA, LLC2017212
+3K170310Alians Clavicle rangeNewclip Technics20170—
+3K161861APTUS® Coronoid 2.0Medartis AG20170—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+3K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+3K141548High Tibial Osteotomy SystemNewclip Technics20153—
+3K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+3K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+3K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K140769Variax 2 SystemStryker Trauma AG201419—
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+3K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+3K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+3K132594Crosscheck Plating SystemSolana Surgical, LLC20132321
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K130510Arthrex Compression PlatesArthrex, Inc.20138—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+3K130774Universal Distal Radius SystemNewclip Technics20135—
+3K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+3K124027Monster Screw SystemApogee Orthosolutions201341—
+3K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+3K122623Short Lateral Superior Clavicle Plate, Left and Right Model 3017-000 (Left) and 3018-000…Advanced Orthopaedic Solutions, Inc.20120—
+3K120903Congruent Bone Plate System: Acu-Loc 2 PlateAcumed, LLC20126—
+3K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+3K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+3K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+3K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC201281
+3K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+3K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—
+3K1032432.4MM VA-LCP Intercarpal Fusion SystemSynthes (Usa)2011187
+3K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+3K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+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—
+3K073375Newdeal Tibiaxys SystemNewdeal Sas2008732
+3K063831Basal Dorsal PlatesNewdeal Sas20070—
+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—