510(k) · Cleared
ClearedMCI - CMF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mci Medical Concept Innovation, Inc. · JEY Plate, Bone
Cleared on Dec 5, 2019 as substantially equivalent to K180204 (Visionare, LLC, 2018) after a 433-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Dec 5, 2019
- Review
- 433 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K980512 (1998). 11 ancestors in all, the oldest K972322 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK980512 Lorenz Reconstruction System with Modular ScrewWalter Lorenz Surgical, Inc. · 1998
- 3 generations backK063052 Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesWalter Lorenz Surgical, Inc. · 2007
- 2 generations backK102641 Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A · 2010
- 1 generation backK180204 CranioMaxillofacial Fixation (CMF) System - CMF VisionareVisionare, LLC · 2018
- This deviceK182758 MCI - CMF SystemMci Medical Concept Innovation, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980512 | Lorenz Reconstruction System with Modular Screw | Walter Lorenz Surgical, Inc. | 1998 | — |
| −3 | K063052 | Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent Plates | Walter Lorenz Surgical, Inc. | 2007 | — |
| −2 | K102641 | Mini and Micro Fragments Reconstruction System-Neoface | Neoortho Produtos Ortopedicos S/A | 2010 | — |
| −1 | K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare | Visionare, LLC | 2018 | — |
| 0 (this device) | K182758 | MCI - CMF System | Mci Medical Concept Innovation, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare Cleared while this submission was under review Summary page 4…el Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate Device K180204 - CranioMaxillofacial Fixation (CMF) System - CMF Visionare - Visionare LLC Reference Devices… | 2018 |
| † | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM) | 1994 |
| † | K943347 | KLS Mini Osteosynthesis System | 1994 |
| † | K083388 | Synthes Matrixorthognathis Fixation System | 2009 |
| † | K091233 | Synthes Matrixmandible Subcondylar Plates | 2009 |
| † | K022185 | Universal CMF System | 2002 |
| † | K182609 | Delphos Implants Rigid Fixation System | 2019 |
| † | K140037 | Optimus CMF System | 2015 |
| † | K160363 | Optimus CMF System | 2016 |
| † | K050934 | Modus Titanium Osteosynthesis System | 2005 |
| † | K091679 | Leforte System Bone Plate | 2009 |
| † | K103778 | Leforte Neuro System Bone Plate | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- 4 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K180204.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
MCI - CMF System is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182758 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182758: MCI - CMF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182758
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026