510(k) Report

Devices descending from K190586

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221342REDEMPTION Beaming SystemVilex, LLC20220—
+1K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+1K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+1K203011Monster Screw SystemParagon 28, Inc.20206—
+1K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+1K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+2K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+2K251555Ultra™ Compression Screw SystemPace Surgical20251—
+2K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+2K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+2K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+2K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+2K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+2K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+2K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+3K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+3K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—