510(k) · Cleared
ClearedCranioMaxillofacial Fixation (CMF) System - CMF Visionare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visionare, LLC · JEY Plate, Bone
Cleared on Dec 28, 2018 as substantially equivalent to K102641 (Neoortho Produtos Ortopedicos S/A, 2010) after a 338-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Dec 28, 2018
- Review
- 338 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980512 (1998). 10 ancestors in all, the oldest K972322 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK980512 Lorenz Reconstruction System with Modular ScrewWalter Lorenz Surgical, Inc. · 1998
- 2 generations backK063052 Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesWalter Lorenz Surgical, Inc. · 2007
- 1 generation backK102641 Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A · 2010
- This deviceK180204 CranioMaxillofacial Fixation (CMF) System - CMF VisionareVisionare, LLC · 2018
- Descendant · cites it directly · 0 of its ownK182758 MCI - CMF SystemMci Medical Concept Innovation, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK182609 Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980512 | Lorenz Reconstruction System with Modular Screw | Walter Lorenz Surgical, Inc. | 1998 | — |
| −2 | K063052 | Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent Plates | Walter Lorenz Surgical, Inc. | 2007 | — |
| −1 | K102641 | Mini and Micro Fragments Reconstruction System-Neoface | Neoortho Produtos Ortopedicos S/A | 2010 | — |
| 0 (this device) | K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare | Visionare, LLC | 2018 | — |
| +1 | K182758 | MCI - CMF System | Mci Medical Concept Innovation, Inc. | 2019 | — |
| +1 | K182609 | Delphos Implants Rigid Fixation System | Delphos Implants - Ind.Com. Importacao E Exportacao DE | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K102641 | Mini and Micro Fragments Reconstruction System-NeofaceSummary page 4…DZL Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate K102641, Mini and Micro Fragments Reconstruction System – NEOFACE, NEOORTHO Produtos Ortopédicos S/A Reference Devices K021642, Synthes… | 2010 |
| † | K021642 | Synthes Craniofacial Plates | 2002 |
| † | K050934 | Modus Titanium Osteosynthesis System | 2005 |
| † | K033065 | Synthes 2.0 MM Craniofacial Locking Plates | 2003 |
| † | K972322 | Lorenz 1.5 MM Neuro Pack/Lorenz 2.0 FT Plates | 1997 |
| † | K080694 | Osteomed Modular Locking Fixation System | 2008 |
| † | K091144 | Synthes Matrixmandible Preformed Reconstruction Plates | 2009 |
| † | K992682 | Modus 2.5 Mandibular Reconstruction Set | 1999 |
| † | K063052 | Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent Plates | 2007 |
| † | K980199 | Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws | 1998 |
| † | K031708 | Osteomed Maxillary/Lefort Iii Distraction System | 2003 |
| † | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM) | 1994 |
| † | K052061 | Modus Imf Screws 2.0 | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K182758 (Mci Medical Concept Innovation, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K102641.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
CranioMaxillofacial Fixation (CMF) System - CMF Visionare 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 as stated in the FDA summary.
https://510kreport.com/device/K180204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180204: CranioMaxillofacial Fixation (CMF) System - CMF Visionare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180204
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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