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.
FDA 510(k) Cleared Appliance, Fixation, Nail/blade/plate Combination, Multiple Component Devices (Product Code KTT)
About Product Code KTT - Regulatory Context
510(k) Submission Activity
403 total 510(k) submissions under product code KTT since 1979, with 403 receiving FDA clearance (average review time: 107 days).
Submission volume has increased in recent years - 18 submissions in the last 24 months compared to 9 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for KTT submissions have been consistent, averaging 103 days recently vs 107 days historically.
KTT devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →