510(k) Report

Devices descending from K000682

340 later devices reach Synthes Large Fragment Dynamic Compression Locking (DCL) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+2K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+2K130009Variax 2 Compression Plating SystemStryker Trauma AG2013271
+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—
+2K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+2K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+2K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+2K113718NCB Straight Narrow Shaft PlatesZimmer GmbH201271
+2K112926Axsos Locking Plate SystemStryker Corp.20110—
+2K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+2K103408Posterior Lateral PlatesDePuy Orthopaedics, Inc.20103—
+2K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc.2010182
+2K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+2K092609Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Synthes (Usa)200951—
+2K032058Modification to Reprocessed Synthes External Fixation DevicesAlliance Medical Corp.20030—
+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—
+3K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+3K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+3K253906Xpert HandNewclip Technics20260—
+3K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K250394Fine TTO™Bodycad Laboratories, Inc.20250—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K250923Fine Osteotomy™Bodycad Laboratories, Inc.20251—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC202511
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+3K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+3K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.20240—
+3K241942TriMed Bridge PlatesTriMed, Inc.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—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+3K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+3K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+3K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+3K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+3K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+3K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K213214Xpert WristNewclip Technics20210—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+3K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+3K200226RetroFixRetrofix Screws, LLC20200—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+3K190830TDM Screw SystemsTdm Co., Ltd.20191—
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+3K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC20191—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20182—
+3K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180—
+3K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+3K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+3K160995NEOVIEW Plating SystemIn2bones Sas201624
+3K153379AxSOS 3TiStryker GmbH201625—
+3K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+3K152000SMV Scientific Bone Plate and Screw SystemSmv Scientific20153—
+3K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+3K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+3K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+3K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+3K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+3K140565Variax 2 Compression Plating SystemStryker Trauma AG20143—