510(k) Report

Devices descending from K003797

53 later devices reach Ace Aim TTC Fusion Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited201211
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K023115Ace VersanailDePuy Orthopaedics, Inc.200241—
+1K012190Aos Modular Femoral NailAdvanced Orthopaedic Solutions, Inc.200110—
+2K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+2K132005Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc.20134—
+2K123569Antegrade Femoral NailAdvanced Orthopaedic Solutions, Inc.20136—
+2K113828Dynanail Ankle Arthrodesis NailMedShape, Inc.201224—
+2K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222…Medshape Solutions201125—
+2K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas2009142
+2K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod.20083—
+2K050882Newdeal Ankle NailNew Deal, S.A.2005155
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+3K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+3K221031Arthrex DualCompression Hindfoot Fusion Nail Implant SystemArthrex, Inc.20220—
+3K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+3K191598AOS ES Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc.20190—
+3K182677DynaNail MiniMedShape, Inc.20195—
+3K181639Panta 2 Arthrodesis Nail SystemIntegra LifeSciences Corporation20180—
+3K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.20182—
+3K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas20181—
+3K171376DynaNail TTC Fusion SystemMedShape, Inc.201722—
+3K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+3K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+3K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc.201173
+4K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+4K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.20260—
+4K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+4K250628DynaNail TTC Fusion SystemMedShape, Inc.20250—
+4K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+4K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+4K203381Dynanail Mini HybridMedShape, Inc.202141
+4K200430Precice® Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20203—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20231—
+5K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+5K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics20260—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123