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FDA issued 471 orthopedic 510(k) clearances in 2021. Orthopedics’ five largest companies received 78 clearances, and we identified 30+ companies that received their first 510(k). Our latest infographic looks at the new products by market segment and company.
Infographic proudly sponsored by Intech
Spine companies were the most active in receiving 510(k) clearances in 2021, accounting for 40% of all clearances. The numbers were not much of a surprise. Spine clearances far outpaced products in other market segments in 2019 and 2020. We documented it in this previous infographic.
Looking closer at the 510(k)s by companies, Stryker, DePuy Synthes, Zimmer Biomet, Smith+Nephew and Medtronic — the five largest orthopedic companies — each received more than 10 clearances. Medacta, which has made a greater push in the U.S. in recent years, topped the list with 24. Additionally, SeaSpine made the list with help from its recently acquired 7D Surgical.
We also identified 33 companies that received their first FDA 510(k) in 2021. Those companies included BioPoly, Biorez and numerous other small companies with U.S. and ex-U.S. headquarters.
Of note, the number of orthopedic 510(k)s decreased last year vs. recent years. We noted 471 510(k)s in 2021, but the number of clearances surpassed 575 in 2019 and 2020. We suspect the decrease is partially due to companies’ and FDA’s preoccupation with the pandemic.
