Cleared Traditional

K252958 - METICULY Patient-specific titanium mesh implant

K252958 is an FDA 510(k) clearance for METICULY Patient-specific titanium mesh..., manufactured by Meticuly Co., Ltd.. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K252958 · Meticuly Co., Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Jan 2026
Decision
120d
Days
Class 2
Risk

K252958 is an FDA 510(k) clearance for the METICULY Patient-specific titanium mesh implant. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Meticuly Co., Ltd. (Bangkok, TH). The FDA issued a Cleared decision on January 14, 2026 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Meticuly Co., Ltd. devices

FDA 510(k) Submission Details - K252958

510(k) Number K252958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 149d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXN Device Classification - Class 2, Special Controls

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Mdr Solutions Co., Ltd.
Paweena U-Thainual

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXN Plate, Cranioplasty, Preformed, Non-alterable

All 55
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