510(k) Report

Devices descending from K123890

36 later devices reach Acumed Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+1K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+1K190830TDM Screw SystemsTdm Co., Ltd.20191—
+1K190586Monster® Screw SystemParagon 28, Inc.201921—
+1K162171S4 Screw System™Subchondral Solutions20173—
+1K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+2K231860TDM Screw SystemTdm Co., Ltd.20240—
+2K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+2K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+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—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+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—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+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—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—