Cleared Traditional

K182711 - Customized Craniofacial Implant (CCI)

K182711 is an FDA 510(k) clearance for Customized Craniofacial Implant (CCI), manufactured by Kelyniam Global, Inc.. The device is a Class 2 Neurology device with product code GWO cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K182711 · Kelyniam Global, Inc. · Neurology device
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May 2019
Decision
236d
Days
Class 2
Risk

K182711 is an FDA 510(k) clearance for the Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI). Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Kelyniam Global, Inc. (Canton, US). The FDA issued a Cleared decision on May 21, 2019 after a review of 236 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. 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 Kelyniam Global, Inc. devices

FDA 510(k) Submission Details - K182711

510(k) Number K182711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2018
Decision Date May 21, 2019
Days to Decision 236 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
88d slower than avg
Panel avg: 148d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWO Device Classification - Class 2, Special Controls

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 Peers - GWO Plate, Cranioplasty, Preformed, Alterable

All 32
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K182711.
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