Advancements in additive manufacturing (AM) have helped expand innovation in orthopedic device design, including use of complex lattice features to further promote bone integration. In keeping pace with the increasing use of AM, FDA has requested supplementary information for 3D-printed device 510(k) submissions — data that they don’t traditionally ask for when reviewing machined products. Accordingly, anticipating regulatory considerations early in the planning process can help avoid pitfalls and maximize the potential for a streamlined project.

This presentation summarizes our experience working with FDA regarding AM orthopedic device 510(k)s, both as a consultant clearing submissions for clients and as a contract manufacturer fabricating the associated prototype, V&V and production parts. Key topics will include test sample strategies, process controls/validation and production monitoring.

SpiTrex Orthopedics Booth #341
Speaker: Jeff Brittan, Vice President of Product Realization