510(k) Report

Devices descending from K112059

10 later devices reach T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+1K152295Talon DistalFix Antegrade/Retrograde Femoral NailOrthopedic Designs North America, Inc.20150—
+1K150655OIC Intramedullary Nail SystemOrthopaedic Implant Company20152—
+1K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A20141—
+1K123745SP2 Femoral Locking Nail, SP2 Tibial Locking NailBiomecanica Industria E Comerico DE Productos Orto20130—
+2K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+2K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+2K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+2K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+3K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—