Cleared Traditional

K210099 - Meticuly Patient-Specific Titanium Mesh Implant (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210099 · Meticuly Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
341d
Days
Class 2
Risk

K210099 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. (Muang Nonthaburi, TH). The FDA issued a Cleared decision on December 21, 2021 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K210099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2021
Decision Date December 21, 2021
Days to Decision 341 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
193d slower than avg
Panel avg: 148d · This submission: 341d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

All 54
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K210099.
EASYMADE-TI
K252251 · CG Bio Co., Ltd. · Apr 2026
METICULY Patient-specific titanium mesh implant
K252958 · Meticuly Co., Ltd. · Jan 2026
Synthes Patient Specific Implants
K243715 · Synthes GmbH · Nov 2025
KLS Martin Cranial Implants - MR Conditional
K252573 · KLS-Martin L.P. · Nov 2025
CustomizedBone Service
K240567 · Fin-Ceramica Faenza S.P.A. · Mar 2024
Longeviti ClearFit OTS Cranial Implant
K231920 · Longeviti Neuro Solutions, LLC · Nov 2023