FDA Product Code GXP: Methyl Methacrylate For Cranioplasty

FDA product code GXP covers methyl methacrylate bone cement used for cranioplasty — surgical reconstruction of skull defects.

These acrylic materials are used to reconstruct cranial bone defects resulting from trauma, tumor resection, or decompressive craniectomy. The cement is molded intraoperatively or prefabricated as a custom implant to restore the contour and protection of the skull vault.

GXP devices are Class II medical devices, regulated under 21 CFR 882.5300 and reviewed by the FDA Neurology panel.

Leading manufacturers include Orthocon, Inc., Biomet, Inc. and Synthes (Usa).