510(k) Report

Devices descending from K101934

25 later devices reach Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182677DynaNail MiniMedShape, Inc.20195—
+1K171376DynaNail TTC Fusion SystemMedShape, Inc.201722—
+1K113828Dynanail Ankle Arthrodesis NailMedShape, Inc.201224—
+2K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+2K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+2K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+2K250628DynaNail TTC Fusion SystemMedShape, Inc.20250—
+2K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+2K221031Arthrex DualCompression Hindfoot Fusion Nail Implant SystemArthrex, Inc.20220—
+2K203381Dynanail Mini HybridMedShape, Inc.202141
+2K200430Precice® Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20203—
+2K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+2K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20231—
+3K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+3K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+3K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+3K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics20260—
+4K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+5K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—