Swedish medical company OssDsign AB (publ) reported on Friday the receipt of US Food and Drug Administration (FDA) 510(k) clearance (K190523) to market its Cranial PSI Accessories in the US.

The company said the Cranial PSI Accessories cleared products are a set of 3D-printed, patient specific accessory devices designed to support and expand clinical use of its patient specific cranioplasty implant already cleared by the FDA. The accessories are designed to make cranial reconstructions safer and easier and to enable new solutions for patients in need of complex cranial reconstructions.

Under its market expansion plans, the company has developed anatomical models, surgical guides and intraoperative implant trials. The accessories are designed to make cranial reconstructions safer, easier and enable new solutions for complex cranial reconstructions.

Following the US FDA clearance, the new accessories, along with the company'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.

In conjunction, the company's Cranial PSI Accessories have already been available on the European market and European neurosurgeons have successfully been able to treat patients for whom no viable surgical solution previously existed.