510(k) Report

Devices descending from K860756

14 later devices reach Grosse and Kempf Locking Nail System, Non-Slot Rod through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120419Dyna Locking Ankle NailU&I Corp.20129—
+1K093707Dyna Locking Trochanteric Nail, Model NG0820U&I Corp.20101—
+1K092771Dyna Locking IM NailU&I Corp.20090—
+1K973944Orthofix Femoral Nailing SytemOrthofix Srl19970—
+2K221084Dyna Locking Trochanteric Nail™Innosys20230—
+2K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+2K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+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—
+3K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+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—