Swedish cranial and facial reconstruction device developer OssDsign said today it won FDA 510(k) clearance for its OssDsign Cranial patient specific implant intended for cranioplasty procedures.
The newly cleared device is designed for procedures to reconstruct cranial defects, the company said. Each unit is personalized and produced using 3D-printing technology out of a proprietary calcium phosphate, reinforced by a titanium skeleton.
“I believe that OssDsign Cranial is a very promising product for cranial bone reconstruction that has led to positive results with two years follow up after introduction. We have used OssDsign Cranial since it was introduced in Sweden; not only does it have good handling characteristics, it also substantially contributes to good outcomes in complex patient groups,” Dr. Lars Kihlström of the Karolinska University Hospital said in a prepared statement.
OssDsign Cranial and its other products have been available in Europe since 2014, the company said, distributed in Germany, the UK and the Nordic region.
The devices are also available in Singapore and Israel, and the company recently inked a deal to distribute them to Italy, Spain, Switzerland, Austria and the Netherlands.
“Receiving FDA clearance for our flagship product OssDsign Cranial is extremely positive news. This means we can continue working according to our existing plan of launching OssDsign Cranial in the US market in Q1 2017. We are in the final stages of setting up an experienced distribution network that will enable OssDsign to rapidly bring the benefits of OssDsign Cranial to surgeons, patients and healthcare systems across the US,” CEO Anders Lundqvist said in prepared remarks.