510(k) Report

Devices descending from K011978

701 later devices reach Synthes LCP Proximal Tibia Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212552Correx SoftwareVilex, LLC20210—
+5K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K211435PAO Cortical ScrewMedacta International S.A.20210—
+5K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+5K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+5K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+5K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+5K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+5K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+5K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+5K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+5K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.20210—
+5K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+5K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K203011Monster Screw SystemParagon 28, Inc.20206—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+5K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+5K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+5K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+5K191636APTUS Foot SystemMedartis AG20190—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K191241AutoStrutOrthospin20194—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K190430OsteoCentric Bone Plate and Screw SystemOsteocentric Trauma20192—
+5K182677DynaNail MiniMedShape, Inc.20195—
+5K182989AURORA™ Screw SystemMiRus, LLC20180—
+5K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+5K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+5K173883External Fixation SystemLife Spine, Inc.20180—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+5K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+5K172886Breakaway Screw SystemParagon 2820174—
+5K172350AxSOS 3 TiStryker GmbH201717—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+5K170727VariAx 2 Compression Plating SystemStryker GmbH20172—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+5K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+5K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+5K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170—
+5K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+5K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+5K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+5K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+5K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+5K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+5K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+5K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+5K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K153378Monster BITE Screw SystemParagon 28201522—
+5K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+5K150871ForeFoot STP SystemTornier, Inc.20150—
+5K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+5K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+5K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+5K150626Rush Medullary PinsZimmer, Inc.20150—
+5K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+5K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+5K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+5K150009BaideJiangsu Baide Medical Intrument Co., Ltd.20151—
+5K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+5K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+5K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+5K141992Variax 2 SystemStryker Trauma AG201422—
+5K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd.20142—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+5K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+5K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+6K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261191Alians Elbow SNewclip Technics20260—
+6K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—