Product Code: GXP FDA class 2 21 CFR 882.5300

Methyl Methacrylate For Cranioplasty

Neurology

Methyl Methacrylate for Cranioplasty is a bone cement-like implant material used intraoperatively to reconstruct cranial defects by molding directly to the patient's skull contour and then hardening in place. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and carries an implant designation due to its permanent placement in the body. The product code is GXP under regulation 21 CFR 882.5300 in the Neurology specialty. The implant flag is active for this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GXP
Device Class: FDA class 2
Regulation Number: 882.5300
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 44 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261265	Permatage XT Settable Bone Putty	Jun 15, 2026	Substantially Equivalent	Orthocon, Inc.
K253732	Permatage Flowable, Settable Bone Paste	Mar 13, 2026	Substantially Equivalent	Orthocon, Inc.
K253854	MONTAGE XT Cranial Cement	Jan 02, 2026	Substantially Equivalent	Orthocon, Inc.
K241027	Permatage Settable Bone Putty	Sep 26, 2024	Substantially Equivalent	Orthocon, Inc.
K232771	Montage Flowable Settable, Resorbable Bone Paste	Feb 16, 2024	Substantially Equivalent	Orthocon, Inc.
K231475	MONTAGE-QS Settable, Resorbable Bone Putty	Oct 12, 2023	Substantially Equivalent	Orthocon, Inc.
K221933	MONTAGE Settable, Resorbable Bone Putty	Jan 13, 2023	Substantially Equivalent	Orthocon, Inc.
K182742	DB-CMF	Jun 20, 2019	Substantially Equivalent	Dimensional Bioceramics, LLC
K162864	OsteoVation Impact	Jan 13, 2017	Substantially Equivalent	Skeletal Kinetics, LLC
K143661	DirectInject	Sep 02, 2015	Substantially Equivalent	Stryker
K102018	NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY	Sep 23, 2010	Substantially Equivalent	Synthes USA Products, LLC
K091382	KRYPTONITE BONE CEMENT	Nov 16, 2009	Unknown	Doctors Research Group, Inc.
K070012	POLYBONE	Dec 27, 2007	Substantially Equivalent	Kyung Won Medical Co., Ltd.
K072601	OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT	Dec 10, 2007	Substantially Equivalent	Osteosymbionics, LLC
K071791	MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280	Jul 30, 2007	Substantially Equivalent	Codman & Shurtleff, Inc.
K060763	STRYKER INJECTABLE CEMENT	Sep 22, 2006	Substantially Equivalent	Stryker
K060445	NORIAN CRS BONE CEMENT	Apr 13, 2006	Substantially Equivalent	Synthes (Usa)
K060443	NORIAN CRS FAST SET PUTTY	Apr 13, 2006	Substantially Equivalent	Synthes (Usa)
K051093	OSTEOPORE PCL SCAFFOLD	Mar 17, 2006	Substantially Equivalent	Osteopore, Inc.
K051784	OSTEOVATION CMF BONE VOID FILLER	Jul 20, 2005	Substantially Equivalent	Skeletal Kinetics, LLC
K043334	BONE SOURCE HAC RAPID SETTING CEMENT	Feb 09, 2005	Substantially Equivalent	Stryker Instruments
K042414	VISIOPLAST ACRYLIC RESIN	Dec 29, 2004	Substantially Equivalent	Tecres
K043280	MIMIX MP BONE VOID FILLER	Dec 21, 2004	Substantially Equivalent	Biomet, Inc.
K042072	CALLOS CMF BONE VOID FILLER	Sep 16, 2004	Substantially Equivalent	Skeletal Kinetics, LLC
K041350	SYNTHES (USA) CHRONOS	Jul 08, 2004	Substantially Equivalent	Synthes (Usa)
K040152	BONE CEMENT FOR CRANIOPLASTY	May 19, 2004	Substantially Equivalent	Cardinalhealth
K032366	BONESOURCE HAC FAST SETTING CEMENT	Oct 30, 2003	Substantially Equivalent	Stryker Instruments
K032307	CAP BONE SUBSTITUTE MATERIAL	Oct 24, 2003	Substantially Equivalent	Etex Corp.
K011399	BIOMET CRANIOFACIAL ACRYLIC CEMENT	May 05, 2003	Substantially Equivalent	Biomet, Inc.
K023575	CONCERT CRANIOPLAST	Jan 22, 2003	Substantially Equivalent	Immedica, Inc.
K023718	QUICKSET MIMIX BONE VOID FILLER	Dec 04, 2002	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K021440	BONESOURCE HAC	Aug 02, 2002	Substantially Equivalent	Stryker Instruments
K012589	FAST SET PUTTY	Feb 07, 2002	Substantially Equivalent	Synthes (Usa)
K011736	DRG QUICKMIX	Jan 30, 2002	Substantially Equivalent	Doctor'S Research Group, Inc.
K012569	MODIFICATION TO: INJECTABLE MIMIX	Dec 21, 2001	Substantially Equivalent	Biomet, Inc.
K994022	PARALLAX CRANIOSET	Aug 31, 2000	Substantially Equivalent	Parallax Medical, Inc.
K990290	CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER	Nov 18, 1999	Substantially Equivalent	Biomet, Inc.
K991398	BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT	Sep 22, 1999	Substantially Equivalent	Stryker Leibinger
K983009	BSM- BONE SUBSTITUTE MATERIAL	Nov 25, 1998	Substantially Equivalent	Etex Corp.
K982040	MEDPOR SURGICAL GRANULE IMPLANTS	Sep 08, 1998	Substantially Equivalent	Porex Surgical, Inc.
K973789	NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC	May 18, 1998	Substantially Equivalent	Norian Corp.
K964537	BONESOURCE HYDROXYAPATITE CEMENT (HAC)	Jan 24, 1997	Substantially Equivalent	Osteogenics, Inc.
K953339	BONESOURCE HYDROXYAPATITE CEMENT (HAC)	Jun 27, 1996	Substantially Equivalent	Osteogenics, Inc.
K873689	CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL	Oct 26, 1987	Substantially Equivalent	Dentsply Intl.