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
+1K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K243469SignexOsteonic Co., Ltd.20250—
+1K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+1K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+1K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+1K231213HKT Anatomical Locking Trauma SystemHankil Tech Medical Co., Ltd.20241—
+1K230623KITE Distal Fibula KitIntrauma S.P.A20230—
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K201321DePuy Synthes 2.7mm VA LCP Clavicle Plate SystemDePuy Synthes202031
+1K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209—
+1K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG202011—
+1K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+1K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+1K181587ORTHOLOC SPS Shoulder Plating SystemTornier, Inc.20181—
+1K181035AOS Small Fragment Plating System LiteAdvanced Orthopaedic Solutions, Inc. (Aos)20181—
+1K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K170727VariAx 2 Compression Plating SystemStryker GmbH20172—
+1K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc201713—
+1K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+1K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+1K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc.20160—
+1K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+1K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+1K152732AOS Small Fragment Plating SystemAvanced Orthopaedic Solutions, Inc. (Aos)20153—
+1K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+1K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+1K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+1K140607Aap Loqtec (R) Olecranon PlateAap Implantate AG20141—
+1K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+1K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical20140—
+1K133452Emerge Medical Small Fragment Locked Plating SystemEmerge Medical20140—
+1K130009Variax 2 Compression Plating SystemStryker Trauma AG2013271
+1K122936Ankle Trauma SystemOrthopro, LLC20131—
+1K120651Stabiliz Fixation SystemStabiliz Orthopaedics, LLC20121—
+1K113652Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self Tapping Loqteq…Aap Implantate AG20128—
+1K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+1K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC201215—
+1K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+1K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+1K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+1K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+1K112663Enhatch Orthopaedics Patient/Technique-Specific HumeralEnhatch Orthopaedics, LLC20120—
+1K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+1K103513Lateral Superior Clavicle Plate, Left and Right; Midshaft Superior Clavicle Plate, Left…Advanced Orthopaedic Solutions, Inc.20111—
+1K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa)201145—
+1K1105923.7MM/5.0MM Dynamic Locking ScrewSynthes USA201102
+1K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa)2011172
+1K1015362.7/3.5MM VA-LCP Anteriro Clavicle Plate SystemSynthes (Usa), LLC201075—
+1K090666PediplatesOrthoPediatrics Corp.200915—
+1K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+1K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSynthes (Usa)2008186—
+1K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH2008256—
+1K072083Small Fragment Locking Plating SystemDePuy Orthopaedics, Inc.2007372
+1K063672Fibula Plate Prolock with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2007251
+1K063487Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH2007257—
+1K062494Ebi Optilock Upper Extremity Plating SystemEbi, L.P.2006221
+1K060710Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 ScrewsZimmer, Inc.20061875
+1K060294Diaphyseal PlateHand Innovations, LLC20062—
+1K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+1K050457Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH2005258—
+1K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc.20036901
+1K011335Synths One-Third Tubular DCL PlateSynthes (Usa)20018402
+2K262649Alians ForearmNewclip Technics20260—
+2K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+2K261191Alians Elbow SNewclip Technics20260—
+2K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K260761APTUS Clavicle System 2.8Medartis AG20260—
+2K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+2K252016Arthrex Humeral NailsArthrex, Inc.20260—
+2K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+2K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+2K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+2K254249HKT Anatomical Locking Trauma SystemHankil Tech Medical Co., Ltd.20260—
+2K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+2K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+2K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+2K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+2K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+2K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+2K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+2K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+2K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+2K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+2K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+2K230805TriMed Clavicle Fixation SystemTriMed, Inc.20230—
+2K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—