Cleared Traditional

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (K182711) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 Peers - GWO Plate, Cranioplasty, Preformed, Alterable

All 13
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K182711.
Stryker PEEK Customized Cranial Implant Kit
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Optimus NEURO System - Sterile Kit
K190811 · Osteonic Co., Ltd. · Nov 2019
Stryker PEEK Customized Cranial Implant Kit
K190229 · Stryker · Jul 2019
Optimus Neuro System
K183352 · Osteonic Co., Ltd. · Jan 2019
Universal Mesh - Sterile
K182425 · Stryker Leibinger GmbH & Co KG · Nov 2018
Stryker Universal Mesh
K170725 · Stryker · Nov 2017