21 C.F.R. § 882.5300
Methyl methacrylate for cranioplasty.
Cite as 21 C.F.R. § 882.5300 (2026)
(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).