Cleared Traditional

METICULY Patient-specific titanium mesh implant

K252958 · Meticuly Co., Ltd. · Neurology
Jan 2026
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K252958 is an FDA 510(k) clearance for the METICULY Patient-specific titanium mesh implant, a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by Meticuly Co., Ltd. (Bangkok, TH). The FDA issued a Cleared decision on January 14, 2026, 120 days after receiving the submission on September 16, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K252958 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2025
Decision Date January 14, 2026
Days to Decision 120 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXN — Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5330

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