Cleared Traditional

K180513 - CustomizedBone Service (FDA 510(k) Clearance)

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

K180513 · Fin-Ceramica Faenza S.P.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
77d
Days
Class 2
Risk

K180513 is an FDA 510(k) clearance for the CustomizedBone Service. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Fin-Ceramica Faenza S.P.A. (Faenza, IT). The FDA issued a Cleared decision on May 15, 2018 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fin-Ceramica Faenza S.P.A. devices

Submission Details

510(k) Number K180513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2018
Decision Date May 15, 2018
Days to Decision 77 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 148d · This submission: 77d
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 K180513.
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