FDA product code GXP: Methyl Methacrylate For Cranioplasty
GXP is the FDA product code for methyl methacrylate for cranioplasty. It is a Class II device, regulated under 21 CFR 882.5300 and reviewed by the Neurology panel. FDA has cleared 45 510(k) submissions under GXP, 8 in the last five years, from 26 different applicants. The average 510(k) review took 153 days (median 109); 156 days on average over the last three years. FDA has posted 30 recalls for GXP devices.
Classification
| Field | Value |
|---|---|
| Device name | Methyl Methacrylate For Cranioplasty |
| Device class | Class II |
| Regulation | 21 CFR 882.5300 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GXP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 92 |
| 2019 | 1 | 265 |
| 2023 | 2 | 170 |
| 2024 | 2 | 161 |
| 2026 | 4 | 150 |
Compare with all 510(k) review times · Search every GXP clearance
Top GXP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthocon, Inc. | 7 | 2026-06-15 |
| Synthes (Usa) | 4 | 2006-04-13 |
| Biomet, Inc. | 4 | 2004-12-21 |
| Skeletal Kinetics, LLC | 3 | 2017-01-13 |
| Stryker Instruments | 3 | 2005-02-09 |
21 more applicants have GXP clearances. See the full list in Caduvo.
Most recent GXP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251959 | T&R BIOFAB CO., Ltd. | TnR Cranial Implant | 2026-07-30 | 399 |
| K261265 | Orthocon, Inc. | Permatage XT Settable Bone Putty | 2026-06-15 | 60 |
| K253732 | Orthocon, Inc. | Permatage Flowable, Settable Bone Paste | 2026-03-13 | 109 |
| K253854 | Orthocon, Inc. | MONTAGE XT Cranial Cement | 2026-01-02 | 30 |
| K241027 | Orthocon, Inc. | Permatage Settable Bone Putty | 2024-09-26 | 164 |
Recalls for GXP devices
30 product recalls in 8 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-04-01.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2020 | 23 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code GXP?
GXP is the FDA product code for methyl methacrylate for cranioplasty. It is a Class II device, regulated under 21 CFR 882.5300 and reviewed by the Neurology panel.
What device class is GXP?
Class II, regulation 21 CFR 882.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code GXP?
Across 45 cleared submissions the average was 153 days from receipt to decision (median 109).
Which companies have the most GXP clearances?
Orthocon, Inc. (7); Synthes (Usa) (4); Biomet, Inc. (4); Skeletal Kinetics, LLC (3); Stryker Instruments (3).
Have GXP devices been recalled?
Yes: 30 product recalls across 8 recall events; the most recent began 2021-04-01.
Next steps
- Run an FDA pathway report with predicate devices for product code GXP
- Run a recall and safety report across every GXP manufacturer
- Watch product code GXP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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