510(k) · Cleared
ClearedMETICULY Patient-specific CMF solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meticuly Co., Ltd. · JEY Plate, Bone
Cleared on Jul 25, 2026 as substantially equivalent to K210731 (KLS-Martin L.P., 2022) after a 302-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Jul 25, 2026
- Review
- 302 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954385 (1996). 15 ancestors in all, the oldest K943347 (1994). No later device cites it as a predicate yet.
- Root · 7 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 6 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 5 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 4 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 3 generations backK163579 KLS Martin Individual Patient SolutionsKLS Martin L.P. · 2017
- 2 generations backK191028 KLS Martin Individual Patient SolutionsKLS-Martin L.P. · 2019
- 1 generation backK210731 KLS Martin Individual Patient SolutionsKLS-Martin L.P. · 2022
- This deviceK253206 METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −6 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −5 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −4 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −3 | K163579 | KLS Martin Individual Patient Solutions | KLS Martin L.P. | 2017 | — |
| −2 | K191028 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2019 | — |
| −1 | K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2022 | — |
| 0 (this device) | K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 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 |
|---|---|---|---|
| * | K210731 | KLS Martin Individual Patient SolutionsSummary page 6…Device Name 510(k) Number KLS-Martin L.P. KLS Martin Individual Patient Solutions K210731 Table 1.2 Reference devices* Applicant Device Name 51… | 2022 |
| † | K943347 | KLS Mini Osteosynthesis System | 1994 |
| † | K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | 2024 |
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 30 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 2 other devices also cite its predicate K210731.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
METICULY Patient-specific CMF solution is intended to serve as a preoperative software system for simulating /evaluating surgical treatment options. It functions as a software and image segmentation system to transfer imaging data from medical scanners, such as a CT-based system. The input data file is processed by the METICULY system to produce output data files. These files may be provided as digital models or used as input in the manufacturing portion…
Read the full statement (134 words)
METICULY Patient-specific CMF solution is intended to serve as a preoperative software system for simulating /evaluating surgical treatment options. It functions as a software and image segmentation system to transfer imaging data from medical scanners, such as a CT-based system. The input data file is processed by the METICULY system to produce output data files. These files may be provided as digital models or used as input in the manufacturing portion of the system to create physical outputs including implants, surgical guides, bone models, splints, and case reports for use in the maxillofacial, midface and mandibular surgery.
METICULY Patient-specific CMF solution implant devices are intended for use in the stabilization, fixation, and reconstruction of maxillofacial / midface and mandibular skeletal regions in adolescents (12 years of age - 21 years of age) and adults.
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/K253206 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253206: METICULY Patient-specific CMF solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253206
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026