510(k) · Cleared
ClearedMETICULY Patient-specific titanium maxillofacial mesh implant
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 Apr 30, 2024 as substantially equivalent to K173039 (Materialise NV, 2018) after a 225-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Apr 30, 2024
- Review
- 225 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K063790 (2007). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK063790 The Synthes Matrixmandible Plate and Screw SystemSynthes (Usa) · 2007
- 2 generations backK170272 TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV · 2017 · Recalled
- 1 generation backK173039 TruMatch CMF Titanium 3D Printed ImplantMaterialise NV · 2018
- This deviceK232889 METICULY Patient-specific titanium maxillofacial mesh implantMeticuly Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K063790 | The Synthes Matrixmandible Plate and Screw System | Synthes (Usa) | 2007 | — |
| −2 | K170272 | TruMatch CMF Titanium 3D Printed Implant System | Materialise NV | 2017 | 2 |
| −1 | K173039 | TruMatch CMF Titanium 3D Printed Implant | Materialise NV | 2018 | — |
| 0 (this device) | K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K173039 | TruMatch CMF Titanium 3D Printed ImplantSummary page 6…Device Name 510(k) Number Materialise NV TruMatch CMF Titanium 3D Printed Implant K173039 Table 1.2 Reference devices* Applicant Device Name… | 2018 |
| † | K191028 | KLS Martin Individual Patient Solutions | 2019 |
| † | K210099 | Meticuly Patient-Specific Titanium Mesh Implant | 2021 |
| † | K112457 | Leforte System Bone Plate & Screw | 2012 |
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 17 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K173039.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 titanium maxillofacial mesh implant is intended for bone fixation and reconstruction,
restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton and midface.
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/K232889 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232889: METICULY Patient-specific titanium maxillofacial mesh implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232889
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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