FDA Product Code JEY: Plate, Bone
FDA product code JEY covers bone plates used in dental and maxillofacial surgery.
These titanium or resorbable plates are used to stabilize osteotomies and fractures of the mandible, maxilla, and midface. They are fixed with bone screws and provide rigid or semi-rigid fixation during healing of the bony segments.
JEY devices are Class II medical devices, regulated under 21 CFR 872.4760 and reviewed by the FDA Dental panel.
Leading manufacturers include Synthes (Usa), Stryker and KLS-Martin L.P..
292
Total
292
Cleared
133d
Avg days
1984
Since
Declining activity -
6 submissions in the last 2 years
vs 8 in the prior period
Review times increasing: avg
160d
recently vs 132d historically
FDA 510(k) Cleared Plate, Bone Devices (Product Code JEY)
292 devices
Cleared
Apr 02, 2026
Leforte MMF System
Jeil Medical Corporation
Dental
258d
Cleared
Dec 19, 2025
Southern Craniomaxillofacial (CMF) System
Southern Medical (Pty) , Ltd.
Dental
80d
Cleared
Nov 07, 2025
Inion CPS 1.5 Baby Bioabsorbable Fixation System
Inion OY
Dental
182d
Cleared
Aug 16, 2024
KLS Martin Oral-Max Implants MR Conditional (bundled)
KLS-Martin L.P.
Dental
98d
Cleared
Jul 12, 2024
MRI Universal
Stryker Leibinger GmbH & Co KG
Dental
127d
Cleared
Jul 11, 2024
tmCMF Solution
Techmah Cmf
Dental
217d
Cleared
Apr 30, 2024
METICULY Patient-specific titanium maxillofacial mesh implant
Meticuly Co., Ltd.
Dental
225d
Cleared
Jan 13, 2024
Stryker Facial iD System
Stryker Craniomaxillofacial
Dental
159d
Cleared
Sep 26, 2023
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
Medcad
Dental
222d
Cleared
Aug 05, 2023
Stryker Resorbable Fixation System
Stryker Leibinger GmbH & Co KG
Dental
142d
Cleared
Dec 09, 2022
Stryker Cutomized Mandible Recon Plate
Stryker Craniomaxillofacial (Cmf)
Dental
99d
Cleared
Nov 10, 2022
Tandry CMF Plate System
Microware Precision Co., Ltd.
Dental
275d
Cleared
Nov 09, 2022
Universal CMF System
Stryker Leibinger GmbH & Co KG
Dental
135d
Cleared
Jul 18, 2022
KLS Martin Individual Patient Solutions
KLS-Martin L.P.
Dental
494d
Cleared
Feb 04, 2022
Stryker Resorbable Fixation System
Stryker Leibinger Micro Implants
Dental
63d
Cleared
Aug 05, 2021
Biomet Microfixation OmniMax MMF System
Biomet Microfixation
Dental
309d
Cleared
Jul 14, 2021
OsteoSync™ Ti Dental Mesh
Sites Medical, LLC
Dental
288d
Cleared
May 19, 2021
TECHFIT Patient-Specific Maxillofacial System
Industrias Medicas Sampedro S.A.S
Dental
194d
Cleared
Feb 12, 2021
MedCAD® AccuPlate® Patient-Specific Plate
Medcad
Dental
443d
Cleared
Sep 10, 2020
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
Synthes USA Products, LLC
Dental
59d
Cleared
Jul 29, 2020
BoniPlus Dental G-Mesh System
Montjade Engineering Co., Ltd.
Dental
670d
Cleared
Jun 17, 2020
Yxoss CBR®
Reoss GmbH
Dental
261d
Cleared
Apr 22, 2020
FAICO CMF System
Faico Medical, LLC
Dental
271d
Cleared
Mar 26, 2020
Stryker Customized Mandible Recon Plate Kit
Stryker
Dental
134d
About Product Code JEY - Regulatory Context
510(k) Submission Activity
292 total 510(k) submissions under product code JEY since 1984, with 292 receiving FDA clearance (average review time: 133 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 8 in the prior period.
FDA 510(k) Review Time - JEY Product Code
Recent submissions under JEY have taken an average of 160 days to reach a decision - up from 132 days historically. Manufacturers should account for longer review timelines in current project planning.
JEY devices are reviewed by the Dental panel. Browse all Dental devices →