FDA breakthrough designations grow since 2019: Where do orthopedic devices stand?


The number of medical devices earning FDA's breakthrough designation has grown exponentially in recent years, and many were given to orthopedic products.

Orthopedic devices earning breakthrough designation in the last year include Premia Spine's Tops system, Theradaptive's Osteo-Adapt SP,  Carlsmed's Aprevo and Auctus Surgical's VBT system.

The breakthrough device designation program allows medtech companies to gain faster review of products deemed to offer more effective treatment or diagnoses for life-threatening conditions, according to the FDA.

As of March 31, 2022, 657 devices earned breakthrough designation since 2015, and the numbers have mounted since 2019, according to data from the FDA.

In 2019, 122 devices gained breakthrough designation. In 2020, that figure was 147, and in 2021, 216 devices got the nod. So far in 2022, 64 devices earned breakthrough status.

Three specialites have dominated breakthrough designations since 2015: cardiology, neurology and orthopedics. The cardiovascular panel granted 158 devices; the neurology panel granted 114 devices and the orthopedic panel allowed 71 products.

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