Bioretec received 510(k) clearance from the FDA for its ActivaScrew Cannulated COM bioabsorbable compression screw.
The clearance enables commercialization of the product in the U.S., according to a Sept. 5 news release.
It covers fixation of bone and osteochondral fractures, osteotomies, arthrodeses and bone grafts of the upper and lower extremities in the presence of appropriate immobilization.
ActivaScrew Cannulated COM is based on the same PLGA material as other products in the Activa product family and uses the same proprietary manufacturing processes. More than 500,000 Activa implants have been sold worldwide.
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