www.fdanews.com/articles/204734-ossdsign-gains-expanded-510k-clearance-for-cranial-implant
OssDsign Gains Expanded 510(k) Clearance for Cranial Implant
October 7, 2021
OssDsign has received an expanded 510(k) clearance from the FDA for its patient-specific cranial implant product, OssDsign Cranial PSI.
The titanium-reinforced calcium phosphate device is designed to reconstruct cranial bone defects. The FDA has now cleared the osteoconductive component of the ceramic material that is resorbed and replaced with bone tissue during the healing process.
The implant “is associated with a low risk of infection in the early postoperative stage, which may otherwise lead to the need for implant removal,” said Stockholm-based Karolinska Development, which counts OssDesign among its portfolio of companies.