510(k) Report

Devices descending from K023115

41 later devices reach Ace Versanail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited201211
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K113828Dynanail Ankle Arthrodesis NailMedShape, Inc.201224—
+1K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222…Medshape Solutions201125—
+1K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas2009142
+1K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod.20083—
+1K050882Newdeal Ankle NailNew Deal, S.A.2005155
+2K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+2K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K221031Arthrex DualCompression Hindfoot Fusion Nail Implant SystemArthrex, Inc.20220—
+2K182677DynaNail MiniMedShape, Inc.20195—
+2K181639Panta 2 Arthrodesis Nail SystemIntegra LifeSciences Corporation20180—
+2K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.20182—
+2K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas20181—
+2K171376DynaNail TTC Fusion SystemMedShape, Inc.201722—
+2K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+2K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+2K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc.201173
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+3K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.20260—
+3K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K250628DynaNail TTC Fusion SystemMedShape, Inc.20250—
+3K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+3K203381Dynanail Mini HybridMedShape, Inc.202141
+3K200430Precice® Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20203—
+3K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+3K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+4K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20231—
+4K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics20260—
+5K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123