OssDsign receives approval for Cranial PSI in USDecember 6, 2019
OssDsign AB announced that the US FDA has granted 510(k) clearance (K190523) to market OssDsign Cranial PSI Accessories in the US.
The 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 accessories are designed to make cranial reconstructions safer and easier and to enable new solutions for patients in need of complex cranial reconstructions.
The new accessories will provide neurosurgeons the possibility to remove bone tumours or otherwise diseased bony tissue and perform cranial reconstruction in a single-stage procedure. One less surgical intervention can greatly reduce patient trauma while saving time and resources for hospitals.
Cranial PSI Accessories have already been available on the European market.