510(k) Report

Devices descending from K070525

60 later devices reach Charlotte 7.0 Multi-Use Compression Screw and Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152062BIOFOAM Bone WedgeWrightmedicaltechnologyinc201611—
+1K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+1K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+2K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+2K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+2K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+2K202326BESPA Charcot SystemBespa Global, LLC20210—
+2K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+2K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+2K182677DynaNail MiniMedShape, Inc.20195—
+2K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+2K172294Osteotomy Truss System (OTS)4Web, Inc.201810—
+2K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+2K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+2K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+3K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K220463Osteotomy Truss System (OTS)4Web Medical, Inc.20221—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K201314Restor3d Utility WedgeRestor3D, Inc.20217—
+3K203381Dynanail Mini HybridMedShape, Inc.202141
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K193366T2 ICFStryker GmbH20201—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC20260—
+4K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+4K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+4K240388Osteotomy Truss System (OTS)4Web Medical, Inc.20240—
+4K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+4K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+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—
+5K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.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—