Cleared Traditional

CustomizedBone Service (K180513) - 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
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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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory and Clinical Research Institute, Inc.
Mary Beth Henderson

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 24
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K180513.
CustomizedBone Service
K193547 · Fin-Ceramica Faenza S.P.A. · Jan 2020
Longeviti ClearFit Cranial Implant
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Longeviti PMMA Static Cranial Implant
K170410 · Longeviti Neuro Solutions, LLC · Mar 2018
CRAINFIX 2 TITANIUM CLAMP SYSTEM
K122353 · Aesculap, Inc. · Aug 2012
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
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