510(k) Report

Devices descending from K063487

257 later devices reach Merete BLP Small Fragment Locking Bone Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+4K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+4K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+4K150009BaideJiangsu Baide Medical Intrument Co., Ltd.20151—
+4K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K141992Variax 2 SystemStryker Trauma AG201422—
+4K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd.20142—
+4K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261191Alians Elbow SNewclip Technics20260—
+5K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+5K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+5K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+5K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+5K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+5K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.20250—
+5K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+5K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+5K230204ALPHALOK Plating SystemVilex, LLC20230—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+5K221558ALPHALOK Plating SystemVilex, LLC20222—
+5K221395Footmotion Plating SystemNewclip Technics20220—
+5K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+5K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K213214Xpert WristNewclip Technics20210—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+5K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+5K200226RetroFixRetrofix Screws, LLC20200—
+5K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+5K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+5K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+5K190830TDM Screw SystemsTdm Co., Ltd.20191—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K173641Activ AnkleNewclip Technics20183—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K170843Alians Fragment SpecificNewclip Technics20171—
+5K170771VariAx 2 Foot SystemStryker GmbH20170—
+5K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+5K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K151769Anchorage 2 CP SystemStryker GmbH20150—
+5K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+6K262344Large Compression ScrewsTriMed, Inc.20260—