5 regulatory pathways to get an orthopedic device cleared in the US

When developing a new orthopedic device or product, you need to consider the most appropriate FDA pathway to take. Most of us have the most experience with 510(k)s but there are 4 other pathways.

Let’s review.

The US Food and Drug Administration (FDA) has several regulatory pathways for medical devices to be cleared for marketing in the United States. They include:

1/510(k) clearance: This is the most common pathway for medical devices to be cleared by the FDA. A device is eligible for 510(k) clearance if it is substantially equivalent to a legally marketed device that is already on the market.


  • Knee replacement implants
  • Intervertebral spinal fusion devices
  • Lumbar artificial disc replacements

2/De Novo classification: This pathway is for new medical devices that do not have a predicate device to reference for substantial equivalence. De Novo is an expedited review process for low- to moderate-risk medical devices.


  • 3D printed spinal implants
  • Novel joint reconstruction devices

3/Premarket Approval (PMA): This is the most stringent regulatory pathway for medical devices. PMA is required for high-risk medical devices, such as implantable devices, and involves a comprehensive review of clinical and laboratory data.


  • Total hip replacement systems
  • Artificial heart valves
  • Implantable spinal cord stimulators

4/Emergency Use Authorization (EUA): This pathway is used to provide rapid access to medical devices during public health emergencies, such as pandemics.


Sterilization and disinfection systems for reusable orthopedic instruments during a public health emergency

5/Humanitarian Device Exemption (HDE): This pathway is for medical devices intended to treat or diagnose a disease or condition that affects fewer than 4,000 people in the United States per year.


Devices for the treatment of rare orthopedic conditions, such as achondroplasia (dwarfism).