510(k) Report

Devices descending from K000684

965 later devices reach Small Fragment Dynamic Compression Locking (DCL) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K131834Wolf Long Bone Plate SystemToby Orthopaedics20130—
+2K132502Variax 2 SystemStryker Trauma AG201321—
+2K131636Polarus ConnectAcumed, LLC20130—
+2K131764Acumed Wrist Spanning PlateAcumed, LLC20137—
+2K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+2K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130—
+2K131480Emerge Medical Locking One-Third Tubular Plate SystemEmerge Medical20130—
+2K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+2K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+2K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+2K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+2K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc.20135—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+2K120787Merete Locking Bone Plate System IiiMerete Medical GmbH201212—
+2K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+2K122623Short Lateral Superior Clavicle Plate, Left and Right Model 3017-000 (Left) and 3018-000…Advanced Orthopaedic Solutions, Inc.20120—
+2K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+2K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+2K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+2K113718NCB Straight Narrow Shaft PlatesZimmer GmbH201271
+2K112437Arthrex Fracture SystemArthrex, Inc.201191—
+2K112885Zimmer Plates and Screws System Screws OnlyZimmer, Inc.201113515
+2K112926Axsos Locking Plate SystemStryker Corp.20110—
+2K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+2K102785Trimed Radiocarpal Fusion SystemTriMed, Inc.20112—
+2K110201Explor Radial Head Plating SystemBiomet, Inc.20110—
+2K110320Comprehensiveproximal Humeral Plating SystemBiomet Manufacturing Corp20110—
+2K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+2K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+2K102282The Varia Fibula Locked Plating System Line Extension Addition of Straight PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics201077—
+2K102688Merete Locking Bone Plate System IIMerete Medical GmbH20100—
+2K100721Locking Bone Screw Model HCQ04, HCZ04Changzhou Orthmar Medical Instrument Co., Ltd.201013—
+2K101421Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model…DePuy Orthopaedics, Inc.201032—
+2K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+2K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+2K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc.2010182
+2K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+2K093761Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp)20103—
+2K092609Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Synthes (Usa)200951—
+2K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+2K090063Merete Locking Bone Plate SystemMerete Medical, Inc.2009241—
+2K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+2K082527Zimmer Universal Locking System: 3.5 MM Locking Plates and ScrewsZimmer, Inc.20081605
+2K081759NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…Zimmer GmbH2008212
+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—
+2K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+2K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.200793—
+2K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+2K063303Universal Locking System, 2.7MM Plates & ScrewsZimmer, Inc.20061464
+2K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.20065011
+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
+2K051083Acumed Scapula Congruent Bone Plate SystemAcumed, LLC20052—
+2K012655Congruent Bone Plate SystemAcu Med, Inc.200179216
+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—
+3K261511Xpert AnkleNewclip Technics20260—
+3K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+3K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+3K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+3K253906Xpert HandNewclip Technics20260—
+3K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC202511
+3K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+3K243275Equinoxe® Scapula Fracture SystemExactech, Inc.20250—
+3K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+3K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+3K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+3K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+3K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.20240—
+3K241942TriMed Bridge PlatesTriMed, Inc.20240—
+3K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+3K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+3K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+3K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH20240—
+3K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+3K241539Activmotion SNewclip Technics20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K230546SignexOsteonic Co., Ltd.20242—
+3K233311Acumed Wrist Plating SystemAcumed, LLC20243—