OssDsign AB has received an expanded marketing authorization from the U.S. Food and Drug Administration (FDA) for the company's patient-specific cranial implant product OssDsign Cranial PSI. The approval underlines that OssDsign's patented calcium phosphate composition has osteoconductive properties inducing resorption and formation of new bone tissue. The new 510(k) clearance is based on the previous market clearance from 2017 and means that the FDA has now cleared the osteoconductive component of the ceramic material in OssDsign Cranial PSI that is resorbed and replaced with bone tissue during the healing process. OssDsign's titanium-reinforced calcium phosphate implant is designed for the reconstruction of cranial bone defects, an area of treatment where post-operative infections are considered one of the most common complications. Both published data and clinical documentation show that the OssDsign Cranial PSI is associated with a low risk of infection in the early postoperative stage, which may otherwise lead to the need for implant removal.