510(k) Report

Devices descending from K124027

41 later devices reach Monster Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221342REDEMPTION Beaming SystemVilex, LLC20220—
+1K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+1K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+1K190586Monster® Screw SystemParagon 28, Inc.201921—
+1K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+1K151418Monster Screw SystemParagon 28201527—
+2K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+2K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+2K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+2K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+2K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+2K203011Monster Screw SystemParagon 28, Inc.20206—
+2K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+2K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+2K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+2K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+2K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+2K153378Monster BITE Screw SystemParagon 28201522—
+3K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+3K251555Ultra™ Compression Screw SystemPace Surgical20251—
+3K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+3K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+3K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+3K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+3K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+5K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—