Sweden-based cranial and facial implants manufacturer OssDsign has secured the US Food and Drug Administration (FDA) 510(k) clearance for the sale of its OssDsign Cranial PSI in the US.
The device is a patient-specific medical implant designed to reconstruct the cranial defects through a surgical procedure called cranioplasty, which involves use of the patient's own bone or implants made from inert plastic or metal materials such as PEEK or titanium.
Go deeper with GlobalData
OssDsign chief executive officer Anders Lundqvist said: "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."
OssDsign customises its cranial implant for a patient's unique requirements based on the patient's computer tomography (CT) information. Each device is developed utilising advanced computer-assisted design (CAD) and 3D-printing technologies.
The implant is designed with a proprietary calcium phosphate composite strengthened using titanium skeleton.
OssDsign medical devices are available across Germany, the UK, Nordic region, Singapore and Israel.
The firm has recently collaborated with Italy, Spain, Switzerland, Austria and the Netherlands for further expansion of its distribution.
Image: OssDsign cranial implant. Photo: courtesy of OssDsign AB.
