510(k) Report

Devices descending from K011716

117 later devices reach The Uni-Clip Staple through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+9K192592Axis Plating SystemExtremity Medical, LLC20190—
+9K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+10K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+10K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+10K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+10K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+10K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+10K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+10K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+10K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+11K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+11K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+11K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+11K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+11K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+12K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—