FDA product code JEY: Plate, Bone
JEY is the FDA product code for plate, bone. It is a Class II device, regulated under 21 CFR 872.4760 and reviewed by the Dental panel. FDA has cleared 294 510(k) submissions under JEY, 17 in the last five years, from 107 different applicants. The average 510(k) review took 134 days (median 90); 185 days on average over the last three years. FDA has posted 111 recalls for JEY devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Plate, Bone |
| Device class | Class II |
| Regulation | 21 CFR 872.4760 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JEY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 181 |
| 2018 | 7 | 258 |
| 2019 | 6 | 196 |
| 2020 | 6 | 255 |
| 2021 | 4 | 308 |
| 2022 | 5 | 213 |
| 2023 | 2 | 182 |
| 2024 | 5 | 165 |
| 2025 | 2 | 131 |
| 2026 | 3 | 258 |
Compare with all 510(k) review times · Search every JEY clearance
Top JEY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synthes (Usa) | 38 | 2010-12-20 |
| KLS-Martin L.P. | 16 | 2026-08-17 |
| Bioplate, Inc. | 16 | 2008-10-01 |
| Walter Lorenz Surgical, Inc. | 15 | 2007-01-12 |
| Stryker | 13 | 2020-03-26 |
102 more applicants have JEY clearances. See the full list in Caduvo.
Most recent JEY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260137 | KLS-Martin L.P. | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions | 2026-08-17 | 213 |
| K253206 | Meticuly Co., Ltd. | METICULY Patient-specific CMF solution | 2026-07-25 | 302 |
| K252246 | Jeil Medical Corporation | Leforte MMF System | 2026-04-02 | 258 |
| K253373 | Southern Medical (Pty) , Ltd. | Southern Craniomaxillofacial (CMF) System | 2025-12-19 | 80 |
| K251441 | Inion OY | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | 2025-11-07 | 182 |
Recalls for JEY devices
111 product recalls in 23 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2023-06-19.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 5 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code JEY?
JEY is the FDA product code for plate, bone. It is a Class II device, regulated under 21 CFR 872.4760 and reviewed by the Dental panel.
What device class is JEY?
Class II, regulation 21 CFR 872.4760. Typical premarket route: 510(k).
How long does a 510(k) take for product code JEY?
Across 294 cleared submissions the average was 134 days from receipt to decision (median 90).
Which companies have the most JEY clearances?
Synthes (Usa) (38); KLS-Martin L.P. (16); Bioplate, Inc. (16); Walter Lorenz Surgical, Inc. (15); Stryker (13).
Have JEY devices been recalled?
Yes: 111 product recalls across 23 recall events; the most recent began 2023-06-19.
Next steps
- Run an FDA pathway report with predicate devices for product code JEY
- Run a recall and safety report across every JEY manufacturer
- Watch product code JEY 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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