510(k) · Cleared
ClearedMETICULY Patient-specific titanium mesh implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meticuly Co., Ltd. · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Jan 14, 2026 as substantially equivalent to K210099 (Meticuly Co., Ltd., 2021) after a 120-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Jan 14, 2026
- Review
- 120 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K953806 (1996). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 6 generations backK983485 Synthes 1.3 MM Self-Drilling ScrewSynthes (Usa) · 1998
- 5 generations backK021850 Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa) · 2002
- 4 generations backK091686 Leforte Neurosystem Bone ScrewJeil Medical Corporation · 2009
- 3 generations backK112812 Leforte Neuro System Bone PlateJeil Medical Corporation · 2012
- 2 generations backK141452 Leforte Neuro System Bone Plate and ScrewJeil Medical Corporation · 2014
- 1 generation backK210099 Meticuly Patient-Specific Titanium Mesh ImplantMeticuly Co., Ltd. · 2021
- This deviceK252958 METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −6 | K983485 | Synthes 1.3 MM Self-Drilling Screw | Synthes (Usa) | 1998 | — |
| −5 | K021850 | Synthes (Usa) 1.3 MM Craniofacial Screws | Synthes (Usa) | 2002 | — |
| −4 | K091686 | Leforte Neurosystem Bone Screw | Jeil Medical Corporation | 2009 | — |
| −3 | K112812 | Leforte Neuro System Bone Plate | Jeil Medical Corporation | 2012 | — |
| −2 | K141452 | Leforte Neuro System Bone Plate and Screw | Jeil Medical Corporation | 2014 | — |
| −1 | K210099 | Meticuly Patient-Specific Titanium Mesh Implant | Meticuly Co., Ltd. | 2021 | — |
| 0 (this device) | K252958 | METICULY Patient-specific titanium mesh implant | Meticuly Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 GXN? 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 GXN device
- #1 K260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti…score 13.7 · 8 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 |
|---|---|---|---|
| * | K210099 | Meticuly Patient-Specific Titanium Mesh ImplantSummary page 6…Device Name 510(k) Number Meticuly Co., Ltd. METICULY Patient-specific titanium mesh implant K210099 Table 1.2 Reference devices* Applicant Device Name… | 2021 |
| † | 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 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 1 other device also cites its predicate K210099.
How does its category compare?
All GXN devicesGXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GXN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXN
69in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXN
6in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXN
24in 2025
MAUDE reports naming product code GXN, 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 | 2 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 23 |
| 2011 | 2 | — | 0 | 20 |
| 2012 | 3 | 102 | 0 | 29 |
| 2013 | 1 | — | 0 | 57 |
| 2014 | 2 | — | 0 | 60 |
| 2015 | 2 | — | 0 | 47 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 74 |
| 2018 | 3 | 199 | 6 | 56 |
| 2019 | 0 | — | 0 | 54 |
| 2020 | 5 | 33 | 0 | 63 |
| 2021 | 3 | 69 | 0 | 63 |
| 2022 | 2 | — | 0 | 57 |
| 2023 | 1 | — | 0 | 32 |
| 2024 | 1 | — | 0 | 35 |
| 2025 | 2 | — | 0 | 24 |
| 2026 | 4 | 193 | 0 | — |
What is it indicated for?
METICULY Patient-specific titanium mesh implant is a device that is designed individually for each patient. This device is indicated for reconstruction of bony defects resulting from selective trauma of the cranial and craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer) during cranial and craniofacial surgery and reconstructive procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252958 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252958: METICULY Patient-specific titanium 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/K252958
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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