GXP · Methyl Methacrylate For Cranioplasty
Neurology · 21 CFR 882.5300 · Class 2
Overview
| Product Code | GXP |
|---|---|
| Device Name | Methyl Methacrylate For Cranioplasty |
| Regulation | 21 CFR 882.5300 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | Permatage Flowable, Settable Bone Paste | Orthocon, Inc. | Mar 13, 2026 | SESE |
| K253854 | MONTAGE XT Cranial Cement | Orthocon, Inc. | Jan 2, 2026 | SESE |
| K241027 | Permatage Settable Bone Putty | Orthocon, Inc. | Sep 26, 2024 | SESE |
| K232771 | Montage Flowable Settable, Resorbable Bone Paste | Orthocon, Inc. | Feb 16, 2024 | SESE |
| K231475 | MONTAGE-QS Settable, Resorbable Bone Putty | Orthocon, Inc. | Oct 12, 2023 | SESE |
| K221933 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | Jan 13, 2023 | SESE |
| K182742 | DB-CMF | Dimensional Bioceramics, LLC | Jun 20, 2019 | SESE |
| K162864 | OsteoVation Impact | Skeletal Kinetics, LLC | Jan 13, 2017 | SESE |
| K143661 | DirectInject | Stryker | Sep 2, 2015 | SESE |
| K102018 | NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY | Synthes USA Products, LLC | Sep 23, 2010 | SESE |
| K091382 | KRYPTONITE BONE CEMENT | Doctors Research Group, Inc. | Nov 16, 2009 | SESU |
| K070012 | POLYBONE | Kyung Won Medical Co., Ltd. | Dec 27, 2007 | SESE |
| K072601 | OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT | Osteosymbionics, LLC | Dec 10, 2007 | SESE |
| K071791 | MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 | Codman & Shurtleff, Inc. | Jul 30, 2007 | SESE |
| K060763 | STRYKER INJECTABLE CEMENT | Stryker | Sep 22, 2006 | SESE |
| K060445 | NORIAN CRS BONE CEMENT | Synthes (Usa) | Apr 13, 2006 | SESE |
| K060443 | NORIAN CRS FAST SET PUTTY | Synthes (Usa) | Apr 13, 2006 | SESE |
| K051093 | OSTEOPORE PCL SCAFFOLD | Osteopore, Inc. | Mar 17, 2006 | SESE |
| K051784 | OSTEOVATION CMF BONE VOID FILLER | Skeletal Kinetics, LLC | Jul 20, 2005 | SESE |
| K043334 | 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
