GXP · Class II · 21 CFR 882.5300

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).

45
Total
45
Cleared
153d
Avg days
1987
Since
Growing category - 5 submissions in the last 2 years vs 3 in the prior period
Consistent review times: 152d avg (recent)

FDA 510(k) Cleared Methyl Methacrylate For Cranioplasty Devices (Product Code GXP)

45 devices
1–24 of 45
Cleared Jun 15, 2026
Permatage XT Settable Bone Putty
K261265
Orthocon, Inc.
Neurology · 60d
Cleared Mar 13, 2026
Permatage Flowable, Settable Bone Paste
K253732
Orthocon, Inc.
Neurology · 109d
Cleared Jan 02, 2026
MONTAGE XT Cranial Cement
K253854
Orthocon, Inc.
Neurology · 30d
Cleared Sep 26, 2024
Permatage Settable Bone Putty
K241027
Orthocon, Inc.
Neurology · 164d
Cleared Feb 16, 2024
Montage Flowable Settable, Resorbable Bone Paste
K232771
Orthocon, Inc.
Neurology · 158d
Cleared Oct 12, 2023
MONTAGE-QS Settable, Resorbable Bone Putty
K231475
Orthocon, Inc.
Neurology · 143d
Cleared Jan 13, 2023
MONTAGE Settable, Resorbable Bone Putty
K221933
Orthocon, Inc.
Neurology · 196d
Cleared Jun 20, 2019
DB-CMF
K182742
Dimensional Bioceramics, LLC
Neurology · 265d
Cleared Sep 02, 2015
DirectInject
K143661
Stryker
Neurology · 253d
Cleared Sep 23, 2010
NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
K102018
Synthes USA Products, LLC
Neurology · 66d
Cleared Jul 30, 2007
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
K071791
Codman & Shurtleff, Inc.
Neurology · 28d
Cleared Sep 22, 2006
STRYKER INJECTABLE CEMENT
K060763
Stryker
Neurology · 185d
Cleared Apr 13, 2006
NORIAN CRS FAST SET PUTTY
K060443
Synthes (Usa)
Neurology · 51d
Cleared Apr 13, 2006
NORIAN CRS BONE CEMENT
K060445
Synthes (Usa)
Neurology · 51d
Cleared Feb 09, 2005
BONE SOURCE HAC RAPID SETTING CEMENT
K043334
Stryker Instruments
General & Plastic Surgery · 68d
Cleared Dec 21, 2004
MIMIX MP BONE VOID FILLER
K043280
Biomet, Inc.
Neurology · 25d
Cleared Jul 08, 2004
SYNTHES (USA) CHRONOS
K041350
Synthes (Usa)
Neurology · 49d
Cleared Oct 30, 2003
BONESOURCE HAC FAST SETTING CEMENT
K032366
Stryker Instruments
Neurology · 90d
Cleared May 05, 2003
BIOMET CRANIOFACIAL ACRYLIC CEMENT
K011399
Biomet, Inc.
Neurology · 728d
Cleared Dec 04, 2002
QUICKSET MIMIX BONE VOID FILLER
K023718
Walter Lorenz Surgical, Inc.
Neurology · 29d
Cleared Aug 02, 2002
BONESOURCE HAC
K021440
Stryker Instruments
General & Plastic Surgery · 88d
Cleared Feb 07, 2002
FAST SET PUTTY
K012589
Synthes (Usa)
Neurology · 181d
Cleared Dec 21, 2001
MODIFICATION TO: INJECTABLE MIMIX
K012569
Biomet, Inc.
Neurology · 134d
Cleared Nov 18, 1999
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
K990290
Biomet, Inc.
Neurology · 293d

About Product Code GXP - Regulatory Context

510(k) Submission Activity

45 total 510(k) submissions under product code GXP since 1987, with 45 receiving FDA clearance (average review time: 153 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GXP Product Code

FDA review times for GXP submissions have been consistent, averaging 152 days recently vs 154 days historically.

GXP devices are reviewed by the Neurology panel. Browse all Neurology devices →