Cleared Traditional

Longeviti ClearFit™ OTS Cranial Implants (K212058) - FDA 510(k) Clearance

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

K212058 · Longeviti Neuro Solutions, LLC · Neurology device
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Sep 2021
Decision
69d
Days
Class 2
Risk

K212058 is an FDA 510(k) clearance for the Longeviti ClearFit™ OTS Cranial Implants. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Longeviti Neuro Solutions, LLC (Hunt Valley, US). The FDA issued a Cleared decision on September 8, 2021 after a review of 69 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 Longeviti Neuro Solutions, LLC devices

Submission Details

510(k) Number K212058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2021
Decision Date September 08, 2021
Days to Decision 69 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
79d faster than avg
Panel avg: 148d · This submission: 69d
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 24
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K212058.
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Longeviti ClearFit Cranial Implant
K203349 · Longeviti Neuro Solutions, LLC · Dec 2020
Longeviti ClearFit Cranial Implant
K202901 · Longeviti Neuro Solutions, LLC · Oct 2020