510(k) Report

Devices descending from K051590

33 later devices reach T2 Ankle Arthrodesis Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+1K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas20181—
+1K163589SIGN IM NailSign Fracture Care International20170—
+1K130051611 Ankle Fusion NailTornier S.A.S.20130—
+1K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited201211
+1K120419Dyna Locking Ankle NailU&I Corp.20129—
+1K102577Force Medical IM Nail SystemForce Medical, Inc.20120—
+1K112982Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Small Bone Innovations, Inc.201211—
+1K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc.201173
+1K100925Ascension Ankle Fusion Nail SystemAscension Orthopedics, Inc.20101—
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250—
+2K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+2K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+2K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+2K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+2K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+2K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc.20170—
+2K130147Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc.20139—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+3K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K230512Gamma4 SystemStryker GmbH20230—
+3K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+3K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+4K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K222309Gamma4 SystemStryker GmbH20220—
+4K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—