The Orthopedic Devices Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patients have access to innovative orthopedic devices that are safe and effective. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).

Orthopedic and Medical Devices

The orthopedics space is continually evolving. Musculoskeletal disorders such as degenerative conditions, trauma, and deformities cover a broad range such as osteoarthritis, bone fracture, joint dislocation, and scoliosis. Common medical devices used for orthopedic applications include, but are not limited to:

• Joint replacement implants, such as total hip arthroplasty and finger joint replacement
• Spine stabilization implants, such as spinal rods, screws, and fixation plates
• Restorative and/or regenerative implants, such as bone morphogenetic proteins and cartilage scaffolds
• Instruments that accompany implants, such as inserters, drivers, and surgical tools.

The FDA evaluates orthopedic medical device submissions using a variety of characterization methods. However, the development of new technologies, discovery of new data, and ever-changing patient needs create an environment where regulatory knowledge gaps develop quickly.

Regulatory Science Gaps and Challenges

Major regulatory science gaps and challenges that drive the Orthopedic Devices Program are:

• Lack of established test methods that evaluate preclinical performance of innovative orthopedic solutions.
• Limitations with existing test methods due to delayed incorporation of either past performance or real-world data in non-clinical assessment of orthopedic devices.
• Inefficient adoption of computational techniques with the potential to supplement and expedite physical tests.

The Orthopedic Devices Program is intended to fill these knowledge gaps by performing or investigating mechanical in vitro (bench) methods, forensic analyses, functional performance evaluation, and computational modeling to inform the regulatory science for these devices.

Orthopedic Devices Program Activities

The Orthopedic Devices Program focuses on regulatory science research in these areas:

• Evaluation strategies for assessing preclinical mechanical, clinical functional, and biological performance of novel orthopedic devices.
• Experimental and computational frameworks to examine failure mechanisms of orthopedic devices, for example mechanical bench models to simulate in vivo device failure.
• Computational models and bench tests for examining mechanical and functional performance of total joint replacement devices.
• Preclinical test methods to better predict, for example, the clinical fretting corrosion performance of orthopedic device modular taper connections.

For more information, email [email protected]