Product code JEY— Dental
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- Classification name
- Plate, Bone
- Device class
- Class 2
- Regulation
- 21 CFR 872.4760
- Advisory panel
- Dental
- Total cleared
- 294
- First cleared
- Most recent
Market context for product code JEY
FDA has cleared devices under product code JEY between 1984 and 2026, filed by 106 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code JEY
Adverse events under product code JEY
product code JEY- Injury
- 1,542
- Malfunction
- 2,292
- Total
- 3,834
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code JEY
1–100 of 294- K260137 — KLS Martin IPS Oral-Max Implants - MR Conditional +3 more
- K253206 — METICULY Patient-specific CMF solution
- K252246 — Leforte MMF System
- K253373 — Southern Craniomaxillofacial (CMF) System
- K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
- K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled)
- K240651 — MRI Universal
- K233874 — tmCMF Solution
- K232889 — METICULY Patient-specific titanium maxillofacial mesh implant
- K232350 — Stryker Facial iD System
- K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
- K230733 — Stryker Resorbable Fixation System
- K222650 — Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate
- K220360 — Tandry CMF Plate System
- K221855 — Universal CMF System
- K210731 — KLS Martin Individual Patient Solutions
- K213777 — Stryker Resorbable Fixation System
- K202969 — Biomet Microfixation OmniMax MMF System
- K202918 — OsteoSync Ti Dental Mesh
- K203282 — TECHFIT Patient-Specific Maxillofacial System
- K193280 — MedCAD® AccuPlate® Patient-Specific Plate
- K201944 — DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
- K182759 — BoniPlus Dental G-Mesh System
- K192747 — Yxoss CBR®
- K191997 — FAICO CMF System
- K193136 — Stryker Customized Mandible Recon Plate Kit
- K193143 — Stryker Facial iD Plating System
- K192655 — Depuy Synthes Maxillofacial Portfolio - MR Conditional
- K182758 — MCI - CMF System
- K191028 — KLS Martin Individual Patient Solutions
- K190696 — Stryker Surgeon iD Mandible Recon Plate
- K182609 — Delphos Implants Rigid Fixation System
- K182305 — Stryker Facial iD Plating System
- K180204 — CranioMaxillofacial Fixation (CMF) System - CMF Visionare
- K180249 — OmniPore DUROMAX Surgical Implants
- K180962 — KLS Martin Individual Patient Solutions
- K173039 — TruMatch CMF Titanium 3D Printed Implant
- K170697 — GBR system
- K172354 — OssBuilder System
- K173320 — KLS Martin L1 MMF System
- K163579 — KLS Martin Individual Patient Solutions
- K170773 — Stryker Universal Mesh
- K172572 — Stryker Upper-Face AXS screws and Mid-Face AXS screws
- K170272 — TruMatch CMF Titanium 3D Printed Implant System
- K171364 — MP LeFort I Plates
- K160363 — OPTIMUS CMF SYSTEM
- K152326 — Biomet Microfixation OmniMax MMF System
- K150965 — LeForte System II
- K143730 — GBR System
- K142568 — Stryker MEDPOR TITAN 3D Orbital Floor Implant
- K143336 — Biomet Microfixation OmniMax MMF System
- K143338 — Argulated Locking Plates
- K140037 — OPTIMUS CMF SYSTEM
- K140978 — OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM
- K141764 — TRISTAR BONE GRAFT FIXATION SYSTEM
- K141165 — MATRIXWAVE MMF SYSTEM
- K133461 — STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
- K133304 — RXG DISTRACTION SYSTEM
- K121235 — LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
- K132519 — STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT
- K132600 — FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
- K131289 — I-GEN
- K130840 — SMARTBUILDER SYSTEM (SB1)
- K131674 — PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
- K123786 — STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
- K122647 — SYNTHES PATIENT SPECIFIC PLATE
- K122890 — INION CPS ORBITAL PLATES
- K113567 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
- K122313 — STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM
- K120951 — SMARTBUILDER SYSTEM
- K121589 — BIOMET MICROFIXATION FACIAL PLATING SYSTEM
- K113512 — BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM
- K121574 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
- K120271 — ARTISAN SPACE MAINTENANCE SYSTEM
- K112457 — LEFORTE SYSTEM BONE PLATE & SCREW
- K112064 — RESORB X-G
- K111761 — NEO TITANIUM MESH, CTI-MEM
- K113251 — SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
- K110926 — BONE PLATE; BONE SCREW
- K110259 — ARCHITEX SPACE MAINTENANCE SYSTEM
- K103136 — SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
- K103778 — LEFORTE NEURO SYSTEM BONE PLATE
- K102641 — MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE
- K102656 — SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
- K100779 — SUSTAIN SPACE MAINTENANCE SYSTEM
- K091807 — MEDPOR FIXATION SYSTEM
- K091812 — FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS
- K092743 — THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
- K091233 — SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES
- K091679 — LEFORTE SYSTEM BONE PLATE
- K091144 — SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
- K083388 — SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
- K082335 — SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
- K073307 — MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM
- K082757 — MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
- K080862 — SONICWELD RX (RESORB-X)
- K080694 — OSTEOMED MODULAR LOCKING FIXATION SYSTEM
- K081067 — FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
- K080331 — SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
- K072528 — ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.