510(k) Report

Devices descending from K142658

36 later devices reach Biomet Headless Compression and Twist-off Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190586Monster® Screw SystemParagon 28, Inc.201921—
+1K190035Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc.20194—
+1K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+2K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+2K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+2K203011Monster Screw SystemParagon 28, Inc.20206—
+2K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+2K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+2K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+3K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+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—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—