Materialise nets FDA OK for preop guides

3D software developer Materialise has received clearance from the U.S. Food and Drug Administration (FDA) for its 3D-printed patient-specific radius and ulna osteotomy guides for children.

The 3D guides are used to assist orthopedic surgeons with 3D preoperative planning for pediatric patients as young as 7 years old. Pediatric osteotomy planning traditionally has been done with x-ray images to draw surgical plans by hand.

Each 3D-printed surgical guide, created by Materialise in collaboration with the surgeon, is patient-specific and designed to fit on the bone of the patient, according to the company.

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