FDA product code · Dental
JEYPlate, Bone
Product code JEY covers Plate, Bone, a Class II device regulated under 21 CFR 872.4760. FDA has cleared 293 devices in this code, 4 of them in the last 12 months. Median review time across the 293 most recent decisions is 90 days. openFDA lists 111 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.4760
- Review panel
- Dental
- Clearances
- 293
What is happening in JEY right now?
JEY (Plate, Bone) has two findings, most consequential first. 1 first-time filer in the last 12 months, Southern Medical (Pty) , Ltd (K253373). The code is crowded, scoring 71 of 100 — 99 companies hold a clearance here and 4 arrived in the last 12 months (JEY:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253373 |
| Crowding | Context | JEY:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in JEY?
FDA has cleared 293 devices under product code JEY since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | |
| K252246 | Leforte MMF System | Jeil Medical Corporation | |
| K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY | |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | |
| K240651 | MRI Universal | Stryker Leibinger GmbH & Co KG | |
| K233874 | tmCMF Solution | Techmah Cmf | |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | |
| K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad |
How long does FDA review take for JEY?
The median FDA review time for JEY is 90 days, measured across the 293 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in JEY?
openFDA lists 111 recall records against product code JEY. A recall record covers one firm's corrective action and may span many device lots.
Z-2287-2023CompletedMaterialise N.V.
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
Z-0629-2021TerminatedBiomet, Inc.
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Z-2698-2020TerminatedSynthes, Inc.
One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.
Z-2739-2020TerminatedSynthes Produktions GmbH
One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).
Z-1484-2020TerminatedMaterialise N.V.
Custom surgical kits contain a plate different than indicated by the package labeling.
Showing the 5 most recently initiated of 111. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for JEY?
MAUDE holds 2,206 adverse-event reports naming product code JEY, 619 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in JEY unusual?
2 months sit above JEY's own expected range: 1 July 2025, 1 October 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 23 | Insufficient history | No expected range — too little history | |
| 47 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 88 | Insufficient history | No expected range — too little history | |
| 35 | Insufficient history | No expected range — too little history | |
| 50 | Insufficient history | No expected range — too little history | |
| 35 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 36 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 57 | Insufficient history | No expected range — too little history | |
| 33 | Insufficient history | No expected range — too little history | |
| 39 | Insufficient history | No expected range — too little history | |
| 103 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 128 | Insufficient history | No expected range — too little history | |
| 62 | Insufficient history | No expected range — too little history | |
| 88 | Insufficient history | No expected range — too little history | |
| 59 | Insufficient history | No expected range — too little history | |
| 44 | 6–123 | Within expected (6–123) | |
| 19 | 3–100 | Within expected (3–100) | |
| 52 | 0–103 | Within expected (0–103) | |
| 83 | 0–105 | Within expected (0–105) | |
| 53 | 2–109 | Within expected (2–109) | |
| 70 | 4–110 | Within expected (4–110) | |
| 178 | 16–178 | Above expected (16–178) | |
| 65 | 22–159 | Within expected (22–159) | |
| 84 | 19–159 | Within expected (19–159) | |
| 160 | 29–143 | Above expected (29–143) | |
| 39 | 31–164 | Within expected (31–164) | |
| 151 | 12–165 | Within expected (12–165) | |
| 40 | 24–223 | Within expected (24–223) | |
| 79 | 0–170 | Within expected (0–170) | |
| 32 | 3–177 | Within expected (3–177) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in JEY.
Who has entered JEY in the last year?
One company filed in JEY for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Southern Medical (Pty) , Ltd. | K253373 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in JEY?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in JEY?
Across the 293 most recent decisions, these applicants filed most often in JEY.
| Applicant | Recent clearances |
|---|---|
| Synthes (Usa) | 38 |
| Bioplate, Inc. | 16 |
| KLS-Martin L.P. | 15 |
| Walter Lorenz Surgical, Inc. | 15 |
| Stryker | 13 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in JEY files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| KLS-Martin L.P. | 18 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch JEY
Get an email the morning anything changes in JEY — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.