Anika Gains FDA Clearance for HA-based Bone Void Filler

By Julie A. Vetalice

Anika Therapeutics received FDA 510(k) clearance to market a resorbable, injectable hyaluronic acid-based bone void filler, SCS 17-01.

As we noted in coverage of ANIK's 3Q17 revenue, the company had submitted the application within 3Q17.

Orthopaedic surgeon John Tierney, D.O., who has worked with the product, remarked, "Anika’s 510(k) clearance allows for the marketing of one of only a handful of bone graft substitutes that can be administered in a minimally invasive manner. It offers physicians an additional option for treating bone defects or injuries, without the need for expensive and high risk surgeries, while also reducing the operating room time spent on each case."

Sources: Anika Therapeutics, Inc.; FDA.gov; ORTHOWORLD Inc.

 

Product Labels: Synthetic Bone Graft

Tags: 510(k) Clearance, Regulatory