510(k) Report

Devices descending from K021786

27 later devices reach Titanium Ankle Arthrodesis Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120419Dyna Locking Ankle NailU&I Corp.20129—
+1K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc.201173
+1K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas2009142
+1K081243Biomet Phoenix Ankle Nail SystemBiomet Trauma200818—
+1K050882Newdeal Ankle NailNew Deal, S.A.2005155
+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—
+2K181639Panta 2 Arthrodesis Nail SystemIntegra LifeSciences Corporation20180—
+2K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas20181—
+2K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+2K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+2K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+2K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited201211
+2K102577Force Medical IM Nail SystemForce Medical, Inc.20120—
+3K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250—
+3K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+3K163589SIGN IM NailSign Fracture Care International20170—
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611