OssDsign’s Cranial Implant Tools Cleared

OssDsign received 510(k) clearance for its Cranial patient-specific implant (PSI) accessories, a set of 3D-printed devices used for optimal implantation of the company’s cranioplasty implant.

The Cranial PSI is an implant that reconstructs defects in the skull, protects the brain and improves the cosmetic appearance of individual patients.

Using the tools alongside the company’s PSI implant, neurosurgeons can remove bone tumors and diseased bony tissue and perform cranial reconstruction in a single stage procedure, reducing patient trauma.