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
+3K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+3K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing20151718
+3K143331Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc.20154—
+3K150121Zimmer Periarticular Plating SystemZimmer, Inc.201509
+3K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+3K143139Arthrex Fracture SystemArthrex, Inc.20151—
+3K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+3K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+3K143066Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile…Zimmer, Inc.201412—
+3K142836Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc.20145—
+3K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+3K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+3K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+3K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+3K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+3K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+3K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K140769Variax 2 SystemStryker Trauma AG201419—
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+3K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K132642Locking Plate SystemBeijing Libeier Bio-Engineering Institute Co., Ltd.20130—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+3K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+3K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+3K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+3K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+3K124027Monster Screw SystemApogee Orthosolutions201341—
+3K130340Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd.20137—
+3K123000Integra Total Foot SystemsIntegra LifeSciences Corporation201254—
+3K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+3K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+3K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH201262
+3K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+3K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+3K112798Locking Compression Plate SystemShanghai Microport Orthopedics Co., Ltd.20120—
+3K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+3K112085Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC20114—
+3K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+3K112406Peri-Loc Proximal Femur Locking Bone PlatesSmith & Nephew, Inc.20113—
+3K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—
+3K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+3K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+3K110271Maestro Wrist Plating SystemBiomet Manufacturing Corp20110—
+3K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+3K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+3K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+3K102998Congruent Bone Plate SystemAcumed, LLC201191—
+3K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+3K100944Clavicle Locking Plate SystemNewclip Technics20109—
+3K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+3K101696Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc.201010—
+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—
+3K091156Trimed Sterile ProductTriMed, Inc.20090—
+3K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+3K083654Zimmer Universal Locking System 2.7 MM Locking Plates and Screws ( Tivanium TI-6A1-4V…Zimmer, Inc.2009122
+3K080184Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2008151
+3K071715Acumed Congruent Bone Plate SystemAcumed, LLC200734—
+3K063095Humerus Locking Plating SystemNewclip Technics20064—
+3K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+3K063460Acumed Congruent Bone Plate SystemAcumed, LLC200621—
+3K052368Olecranonplate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH200551
+3K052152B-Bop PlateNew Deal, S.A.20051—
+3K051410Acumed Rib Congrient Bone Plate SystemAcumed, LLC200591
+3K050852Claviculaplate with Angular Stablity Bone Plate SystemI.T.S. Implantat-Technologie-Systeme GmbH2005381
+3K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004249—
+3K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC20049810
+3K021626Hallu PlatesNew Deal, S.A.2002280—
+3K021321Wrist Fusion PlateAcu Med, Inc.2002113—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K261038Xpert PFPNewclip Technics20260—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+4K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+4K254182AsterOsteonic Co., Ltd.20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+4K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K251620A.L.P.S. Proximal Humerus Plating SystemZimmer Biomet20250—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K250155Xpert KneeNewclip Technics20250—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—