The company has been granted 510(k) clearance by the US Food and Drug Administration (FDA) to market OssDsign Cranial PSI Accessories in the US.
The cleared products are a set of 3D-printed, patient specific accessory devices designed to support and expand clinical use of OssDsign’s patient specific cranioplasty implant already cleared by the FDA.
The new FDA clearance will enable OssDsign to continue to drive growth in the US by gaining access to additional cohorts of patients with complex cranial defects. The new accessories, along with OssDsign’s novel implant technology, will provide US neurosurgeons the possibility to remove bone tumors or otherwise diseased bony tissue and perform cranial reconstruction in a single stage procedure.
Photo of Anders Lundqvist, CEO of OssDsign