510(k) Report

Devices descending from K162353

33 later devices reach MICATM Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+1K223392REVCON (TM) Screw SystemVoom Medical Devices, Inc.20230—
+1K221645PROstep (TM) MIS 5mm Chamfer Screw SystemWright Medical Technology20230—
+1K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+1K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+1K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+1K183620PROSTEP TBC Implant SystemWrightmedicaltechnologyinc20190—
+1K190586Monster® Screw SystemParagon 28, Inc.201921—
+1K181377PROSTEP MICA Screw SystemWrightmedicaltechnologyinc20190—
+2K254280F.A.S.T ScrewSteps Ortho20260—
+2K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+2K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+2K203011Monster Screw SystemParagon 28, Inc.20206—
+2K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+2K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+3K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+3K251555Ultra™ Compression Screw SystemPace Surgical20251—
+3K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+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—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—