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
+5K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+5K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+5K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+5K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K212552Correx SoftwareVilex, LLC20210—
+5K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+5K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+5K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+5K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+5K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+5K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+5K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+5K203011Monster Screw SystemParagon 28, Inc.20206—
+5K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+5K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+5K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+5K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+5K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+5K191636APTUS Foot SystemMedartis AG20190—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K191241AutoStrutOrthospin20194—
+5K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+5K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K182677DynaNail MiniMedShape, Inc.20195—
+5K182989AURORA™ Screw SystemMiRus, LLC20180—
+5K181091AxSOS 3 TiStryker GmbH201811—
+5K182402CoLink View Plating SystemIn2bones USA, LLC20182—
+5K173883External Fixation SystemLife Spine, Inc.20180—
+5K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+5K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20182—
+5K180500VariAx 2 SystemStryker GmbH201812—
+5K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+5K172886Breakaway Screw SystemParagon 2820174—
+5K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+5K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+5K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+5K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+5K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+5K153395OS2-C Compression StapleIn2bones Sas20167—
+5K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K153378Monster BITE Screw SystemParagon 28201522—
+5K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+5K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+5K150871ForeFoot STP SystemTornier, Inc.20150—
+5K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+5K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+5K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+5K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+5K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC20145—
+5K141992Variax 2 SystemStryker Trauma AG201422—
+5K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+5K111266Easylock OsteosystemTriMed, Inc.20110—
+5K111326Osteowedge Opening Wedge Bone Locking SystemGraham Medical Technologies, LLC20111—
+5K103705Low Profile ScrewsArthrex, Inc.2011219—
+5K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc.201056—
+5K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+5K063820Lisfranc PlateNew Deal, S.A.20070—
+5K070241Modification to Lapidus PlateNew Deal, S.A.200701
+6K262975Arthrex Beaming SystemArthrex, Inc.20260—
+6K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+6K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+6K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+6K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+6K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+6K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+6K251555Ultra™ Compression Screw SystemPace Surgical20251—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—