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).
43
Total
43
Cleared
150d
Avg days
1987
Since
Stable submission activity - 3 submissions in the last 2 years
Review times improving: avg
101d
recently vs 154d historically
FDA 510(k) Cleared Methyl Methacrylate For Cranioplasty Devices (Product Code GXP)
43 devices
Cleared
Mar 13, 2026
Permatage Flowable, Settable Bone Paste
Orthocon, Inc.
Neurology
109d
Cleared
Jan 02, 2026
MONTAGE XT Cranial Cement
Orthocon, Inc.
Neurology
30d
Cleared
Sep 26, 2024
Permatage Settable Bone Putty
Orthocon, Inc.
Neurology
164d
Cleared
Feb 16, 2024
Montage Flowable Settable, Resorbable Bone Paste
Orthocon, Inc.
Neurology
158d
Cleared
Oct 12, 2023
MONTAGE-QS Settable, Resorbable Bone Putty
Orthocon, Inc.
Neurology
143d
Cleared
Jan 13, 2023
MONTAGE Settable, Resorbable Bone Putty
Orthocon, Inc.
Neurology
196d
Cleared
Jun 20, 2019
DB-CMF
Dimensional Bioceramics, LLC
Neurology
265d
Cleared
Apr 13, 2006
NORIAN CRS FAST SET PUTTY
Synthes (Usa)
Neurology
51d
Cleared
Apr 13, 2006
NORIAN CRS BONE CEMENT
Synthes (Usa)
Neurology
51d
Cleared
Dec 21, 2004
MIMIX MP BONE VOID FILLER
Biomet, Inc.
Neurology
25d
Cleared
Jul 08, 2004
SYNTHES (USA) CHRONOS
Synthes (Usa)
Neurology
49d
Cleared
May 05, 2003
BIOMET CRANIOFACIAL ACRYLIC CEMENT
Biomet, Inc.
Neurology
728d
Cleared
Feb 07, 2002
FAST SET PUTTY
Synthes (Usa)
Neurology
181d
Cleared
Dec 21, 2001
MODIFICATION TO: INJECTABLE MIMIX
Biomet, Inc.
Neurology
134d
Cleared
Nov 18, 1999
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
Biomet, Inc.
Neurology
293d
Cleared
Oct 26, 1987
CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
Dentsply Intl.
Neurology
45d
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 510(k) Review Time - GXP Product Code
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 →