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..
FDA 510(k) Cleared Methyl Methacrylate For Cranioplasty Devices (Product Code GXP)
About Product Code GXP - Regulatory Context
510(k) Submission Activity
43 total 510(k) submissions under product code GXP since 1987, with 43 receiving FDA clearance (average review time: 150 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
Recent submissions under GXP have taken an average of 101 days to reach a decision - down from 154 days historically, suggesting improved FDA processing for this classification.
GXP devices are reviewed by the Neurology panel. Browse all Neurology devices →