510(k) Report

Devices descending from K101030

40 later devices reach Modification to HBS Headless Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+2K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+2K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+2K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+2K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+3K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+3K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+3K190830TDM Screw SystemsTdm Co., Ltd.20191—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K162171S4 Screw System™Subchondral Solutions20173—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K231860TDM Screw SystemTdm Co., Ltd.20240—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+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—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+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—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.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—