OssDsign receives expanded FDA market clearance for OssDsign Cranial PSI
Uppsala, October 4, 2021 – OssDsign today announced that it has received expanded market clearance from the US Food and Drug Administration (FDA) for OssDsign Cranial PSI – a patient-specific cranial implant. The clearance highlights the osteoconductive properties of OssDsign's patented calcium phosphate composition to be resorbed and replaced with bone tissue.The new 510(k) clearance builds on an initial market clearance in 2017 and means the FDA has now cleared that the osteoconductive ceramic component of OssDsign Cranial PSI is resorbed and replaced with bone tissue during the healing