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  1. Advancing Regulatory Science

Orthopedic Device Mechanics

CERSI Collaborator: Jeffrey Lotz, PhD, University of California at San Francisco (UCSF)

FDA Collaborators: Anton Dmitriev, PhD, Srinidhi Nagaraja, PhD, Jonathan Peck, MS

Project Start Date: April 2014

Regulatory Science Challenge

Spinal devices such as interbody cages, plates, screws, and rods are used to treat spinal pathologies by stabilizing and/or re-aligning the spinal column. Despite significant technological progress in this arena, there are little data summarizing direct mechanical performance and properties of the most commonly used implants, which may pose research and development challenges for the affected stakeholder groups. Leveraging the accumulated internal knowledge, FDA is positioned to fill the current gap and add to our overall understanding of spinal device design and performance.

Project Description & Goals

Researchers are evaluating design specifications and mechanical performance for certain types of spinal devices while also comparing this information to postmarket data contained in medical devices reports (MDR) submitted to FDA.

The project’s goal is to create a database that features acceptable mechanical performance values for various types of spinal devices, discuss failure mechanisms, and work towards improving the current testing methodologies and criteria. Once aggregated and fully analyzed, these data may aid in future efforts to develop computational models as well as cross-reference observed mechanical failures with those reported in the clinical setting. A better understanding of the performance of these devices could help guide treatment decisions and lead to further improvements in spinal implant design and use.

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