U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
(a) Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.
(b) Classification. Class II (performance standards).