What is a Humanitarian Device?

The Tether is a actually considered a “Humanitarian Use Device”. This is a special approval given to some medical devices by the FDA. The FDA looks at a lot criteria to classify something as a Humanitarian Device, but the most important things they look for are:

  • The patient wouldn’t be exposed to unreasonable or significant risk of illness or injury1
  • The probable benefit to health from use of the device outweighs the risk of injury or illness from its use 1

It also takes into account the possible risks and benefits of other devices or alternative forms of treatment that are on the market today 1.

This criteria is demonstrated to the FDA by showing clinical evidence and extensive testing on the medical device’s performance.

You can read more about our clinical evidence here.

Humanitarian Device Statement:
The Tether is approved as a Humanitarian Device for patient with idiopathic scoliosis with a Cobb angle of 30-65 degrees. Patients should have failed bracing and/or be intolerant to brace wear. There is probable benefit of the device, but its efficacy is still unproven.

1Center for Devices and Radiological Health. (n.d.). Getting a humanitarian use device to market. Retrieved September 5, 2019, from https://www.fda.gov/medicaldevices/humanitarian-device-exemption/getting-humanitarian-use-device-market#:~:text=HDE%20approval%20is%20based%20upon,while%20taking%20into%20account%20the