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
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+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—
+3K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+3K230938ARIX Humerus SystemJeil Medical Corporation20230—
+3K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+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—
+3K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+3K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+3K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+3K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+3K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+3K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+3K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+3K213572JuniOrtho Plating System™Orthofix Srl20220—
+3K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+3K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+3K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+3K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+3K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+3K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+3K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K200226RetroFixRetrofix Screws, LLC20200—
+3K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+3K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+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—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+3K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+3K190830TDM Screw SystemsTdm Co., Ltd.20191—
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K192021NCB Polyaxial Locking Plate SystemZimmer GmbH20191—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+3K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC20191—
+3K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+3K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+3K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+3K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+3K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K162380Locking Plate SystemBeijing Keyi Medical Device Technology Co., Ltd.20170—
+3K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+3K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+3K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+3K160995NEOVIEW Plating SystemIn2bones Sas201624
+3K153379AxSOS 3TiStryker GmbH201625—
+3K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+3K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+3K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+3K151508IRENE Locking Compression Plate SystemTianjin Zhengtian Medical Instrument Co., Ltd.20160—
+3K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+3K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+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—
+3K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+3K143721PRCT2Fx Solutions20150—
+3K151879VariAx 2 One-Third Tubular Plating SystemStryker GmbH20156—
+3K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K150675Dorsal Spanning PlateSkeletal Dynamics, LLC20151—