Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5300](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5300) → GXP — Methyl Methacrylate For Cranioplasty # GXP · Methyl Methacrylate For Cranioplasty _Neurology · 21 CFR 882.5300 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP ## Overview - **Product Code:** GXP - **Device Name:** Methyl Methacrylate For Cranioplasty - **Regulation:** [21 CFR 882.5300](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5300) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **Implant:** yes ## Identification Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 43) Showing 20 most recent of 43 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253732](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K253732.md) | Permatage Flowable, Settable Bone Paste | Orthocon, Inc. | Mar 13, 2026 | SESE | | [K253854](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K253854.md) | MONTAGE XT Cranial Cement | Orthocon, Inc. | Jan 2, 2026 | SESE | | [K241027](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K241027.md) | Permatage Settable Bone Putty | Orthocon, Inc. | Sep 26, 2024 | SESE | | [K232771](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K232771.md) | Montage Flowable Settable, Resorbable Bone Paste | Orthocon, Inc. | Feb 16, 2024 | SESE | | [K231475](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K231475.md) | MONTAGE-QS Settable, Resorbable Bone Putty | Orthocon, Inc. | Oct 12, 2023 | SESE | | [K221933](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K221933.md) | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | Jan 13, 2023 | SESE | | [K182742](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K182742.md) | DB-CMF | Dimensional Bioceramics, LLC | Jun 20, 2019 | SESE | | [K162864](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K162864.md) | OsteoVation Impact | Skeletal Kinetics, LLC | Jan 13, 2017 | SESE | | [K143661](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K143661.md) | DirectInject | Stryker | Sep 2, 2015 | SESE | | [K102018](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K102018.md) | NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY | Synthes USA Products, LLC | Sep 23, 2010 | SESE | | [K091382](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K091382.md) | KRYPTONITE BONE CEMENT | Doctors Research Group, Inc. | Nov 16, 2009 | SESU | | [K070012](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K070012.md) | POLYBONE | Kyung Won Medical Co., Ltd. | Dec 27, 2007 | SESE | | [K072601](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K072601.md) | OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT | Osteosymbionics, LLC | Dec 10, 2007 | SESE | | [K071791](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K071791.md) | MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 | Codman & Shurtleff, Inc. | Jul 30, 2007 | SESE | | [K060763](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K060763.md) | STRYKER INJECTABLE CEMENT | Stryker | Sep 22, 2006 | SESE | | [K060445](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K060445.md) | NORIAN CRS BONE CEMENT | Synthes (Usa) | Apr 13, 2006 | SESE | | [K060443](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K060443.md) | NORIAN CRS FAST SET PUTTY | Synthes (Usa) | Apr 13, 2006 | SESE | | [K051093](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K051093.md) | OSTEOPORE PCL SCAFFOLD | Osteopore, Inc. | Mar 17, 2006 | SESE | | [K051784](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K051784.md) | OSTEOVATION CMF BONE VOID FILLER | Skeletal Kinetics, LLC | Jul 20, 2005 | SESE | | [K043334](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP/K043334.md) | BONE SOURCE HAC RAPID SETTING CEMENT | Stryker Instruments | Feb 9, 2005 | SESE | ## Top Applicants - Orthocon, Inc. — 6 clearances - Biomet, Inc. — 4 clearances - Synthes (Usa) — 4 clearances - Skeletal Kinetics, LLC — 3 clearances - Stryker Instruments — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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