510(k) Report

Devices descending from K792291

80 later devices reach Synthes Reconstructive Plates 'Y' Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+1K990019DRG Medium Screw SystemDolphin Medical Technologies, Inc.19990—
+1K973810DRG Large Screw SystemDolphin Medical Technologies, Inc.19980—
+1K972219Orthopedic Plate SystemFerguson Medical19978—
+1K972217Orthopedic Screw SystemFerguson Medical19970—
+1K960533K3 Bone Screw SystemKinetikos Medical, Inc.199661—
+1K960537K2 Bone Screw SystemKinetikos Medical, Inc.199641—
+2K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+2K023365Leforte System Bone ScrewJeil Medical Corporation200320—
+2K022139Hip Tool ImplantOrthopedic Sciences, Inc.20027—
+3K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+3K131311Arix Foot SystemJeil Medical Corporation20139—
+3K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+3K063709TS-Bone Hip ToolOrthopedic Sciences, Inc.20071—
+3K052538S-Bone Hip ToolOrthopedic Sciences, Inc.20050—
+3K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+3K051032Titanium-Hip ToolOrthopedic Sciences, Inc.20050—
+3K051181Custom-Hip ToolOrthopedic Sciences, Inc.20050—
+3K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc.20041—
+4K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+4K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+4K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+4K190830TDM Screw SystemsTdm Co., Ltd.20191—
+4K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+4K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K170697GBR systemSurgident20182—
+4K162171S4 Screw System™Subchondral Solutions20173—
+4K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K161864ARIX Foot SystemJeil Medical Corporation20165—
+4K143730GBR SystemJeil Medical Corporation20152—
+4K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc.20070—
+4K063033Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc.20060—
+5K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+5K231860TDM Screw SystemTdm Co., Ltd.20240—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K221342REDEMPTION Beaming SystemVilex, LLC20220—
+5K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+5K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+5K203011Monster Screw SystemParagon 28, Inc.20206—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+5K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+6K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+6K251555Ultra™ Compression Screw SystemPace Surgical20251—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—