Product code JEY: 510(k) clearances and predicates
Product code JEY covers 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. FDA lists 294 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
294 clearances on file under product code JEY. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 5 |
| 2023 | 2 |
| 2024 | 5 |
| 2025 | 2 |
| 2026 so far | 3 |
Recent clearances
Newest JEY clearances in the FDA index, with applicant and decision date:
- K260137, 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, applicant KLS-Martin L.P., decided 2026-08-17. FDA record
- K253206, METICULY Patient-specific CMF solution, applicant Meticuly Co., Ltd., decided 2026-07-25. FDA record
- K252246, Leforte MMF System, applicant Jeil Medical Corporation, decided 2026-04-02. FDA record
- K253373, Southern Craniomaxillofacial (CMF) System, applicant Southern Medical (Pty) , Ltd., decided 2025-12-19. FDA record
- K251441, Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System, applicant Inion OY, decided 2025-11-07. FDA record
- K241314, KLS Martin Oral-Max Implants MR Conditional (bundled), applicant KLS-Martin L.P., decided 2024-08-16. FDA record
- K240651, MRI Universal, applicant Stryker Leibinger GmbH & Co KG, decided 2024-07-12. FDA record
- K233874, tmCMF Solution, applicant Techmah Cmf, decided 2024-07-11. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include METICULY Patient-specific CMF solution, Leforte MMF System. Watch new JEY clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code JEY?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JEY clearances include 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.
How many 510(k) clearances use product code JEY?
294 at the time this page was generated, from openFDA records.
How do I find a predicate device under JEY?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new JEY clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.