Cleared Traditional

K212391 - MCI-Neuro Fixation System (FDA 510(k) Clearance)

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

K212391 · Mci Medical Concept Innovation, Inc. · Neurology device
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Oct 2022
Decision
445d
Days
Class 2
Risk

K212391 is an FDA 510(k) clearance for the MCI-Neuro Fixation System. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Mci Medical Concept Innovation, Inc. (Sunrise, US). The FDA issued a Cleared decision on October 21, 2022 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5320 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Mci Medical Concept Innovation, Inc. devices

Submission Details

510(k) Number K212391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2021
Decision Date October 21, 2022
Days to Decision 445 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
297d slower than avg
Panel avg: 148d · This submission: 445d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWO Plate, Cranioplasty, Preformed, Alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5320
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

Passarini Regulatory Affairs/ PR Servicos
Graziela Brum

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 - GWO Plate, Cranioplasty, Preformed, Alterable

All 41
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K212391.
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