Sweden-based OssDsign has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Ossdsign Cranial PSI to market in the country.
Ossdsign Cranial is a patient-specific medical implant, which can be used for reconstruction of cranial defects through cranioplasty surgical procedure.
Neurosurgeons generally carry out cranioplasty by using the patient’s own bone or implants made from inert plastic or metal materials such as PEEK or titanium.
Based on the patient’s computer tomography (CT) information, Ossdsign Cranial is being designed as per patients unique requirements.
The company used advanced computer-assisted design (CAD) and modern 3D-printing technologies to produce the new device.
The device also features proprietary calcium phosphate composite, which is strengthened by titanium skeleton.
Earlier this month, the company announced new commercial partnerships to distribute its medical implants in Italy, Spain, Switzerland, Austria and the Netherlands.
OssDsign CEO 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.”