510(k) Report

FDA applicant

Meticuly Co., Ltd.

Bangkok, TH4 decisions2021–20260 recalls

FDA records 4 decisions for Meticuly Co., Ltd. (Bangkok, TH) from 2021 to 2026: 4 510(k) clearances. Most are in product codes GXN (Plate, Cranioplasty, Preformed, Non-Alterable) and JEY (Plate, Bone). Since 2016 its 510(k)s took a median of 264 days from receipt to decision, against 176 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Meticuly Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12024: 12026 (partial year): 2
2021high 2 (2026) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Meticuly Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Meticuly Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GXNPlate, Cranioplasty, Preformed, Non-Alterable2decisions
  • JEYPlate, Bone2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 264 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 176 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210099Meticuly Patient-Specific Titanium Mesh ImplantMeticuly Co., Ltd. · 20212cite it

What has FDA decided for it lately?

  • K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
  • K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd. · 2026
  • K232889METICULY Patient-specific titanium maxillofacial mesh implantMeticuly Co., Ltd. · 2024
  • K210099Meticuly Patient-Specific Titanium Mesh ImplantMeticuly Co., Ltd. · 2021

All 4 as Meticuly Co., Ltd. →