FDA Product Code KTT: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Under FDA product code KTT, nail/blade/plate combination fixation appliances are cleared for the treatment of peritrochanteric and subtrochanteric hip fractures.
These hybrid implants combine an intramedullary nail or blade with a plate component to provide both axial and rotational stability at the fracture site. They are the standard of care for unstable intertrochanteric femur fractures in elderly patients.
KTT devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Paragon 28, Inc., OrthoPediatrics Corp. and Stryker GmbH.
List of Appliance, Fixation, Nail/blade/plate Combination, Multiple Component devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Appliance, Fixation, Nail/blade/plate Combination, Multiple Component devices (product code KTT). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →