Cleared Traditional

K182711 - Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (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
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 41
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K182711.
TECHFIT Patient-Specific Cranial System
K250297 · Techfit Digital Surgery, Inc. · Oct 2025
Fusion Craniofacial Implant
K250334 · Kelyniam Global, Inc. · Jul 2025
VSP PEEK Cranial Implant
K231834 · 3D Systems, Inc. · Apr 2024
MCI-Neuro Fixation System
K212391 · Mci Medical Concept Innovation, Inc. · Oct 2022
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
K210360 · Osteonic Co., Ltd. · Jan 2022
Stryker PEEK Customized Cranial Implant Kit
K203055 · Stryker · Feb 2021