510(k) Report

Devices descending from K053136

41 later devices reach 5TH Metatarsal Fracture Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183026Wright Jones Fracture SystemWrightmedicaltechnologyinc20191—
+1K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+1K140952Charlotte Carolina Jones Fracture System ScrewWrightmedicaltechnologyinc20145—
+1K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+2K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+2K202326BESPA Charcot SystemBespa Global, LLC20210—
+2K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+2K201319Medline UNITE Jones Fracture Screw SystemMedline Industires, Inc.20200—
+2K191289Bone Screw Line AdditionVilex IN Tennessee, Inc.20192—
+2K182677DynaNail MiniMedShape, Inc.20195—
+2K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+2K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+2K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K203381Dynanail Mini HybridMedShape, Inc.202141
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K193366T2 ICFStryker GmbH20201—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—