The 510(k) process—It’s not broken, so why “fix” it?

By William M. Mihalko, MD, PhD, with Ammar Al-Saraf, Ali Al-Saraf, and Katherine Sale

What changing the 510(k) process means to orthopaedics

Chances are, if you implanted an orthopaedic device today, it arrived in the marketplace via the U.S. Food and Drug Administration’s (FDA) 510(k) program (Figure 1). Since 2003, more than 99 percent of all medical devices have been cleared through this pathway, compared to less than 1 percent approved through the premarket approval (PMA) process.

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