Cleared Traditional

K103582 - KELYNIAM CUSTOM SKULL IMPLANT (CSI)

K103582 is an FDA 510(k) clearance for KELYNIAM CUSTOM SKULL IMPLANT (CSI), manufactured by Kelyniam Global, Inc.. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K103582 · Kelyniam Global, Inc. · Neurology device
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Apr 2011
Decision
127d
Days
Class 2
Risk

K103582 is an FDA 510(k) clearance for the KELYNIAM CUSTOM SKULL IMPLANT (CSI). Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Kelyniam Global, Inc. (New Britain, US). The FDA issued a Cleared decision on April 14, 2011 after a review of 127 days - within the typical 510(k) review window.

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: 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 - K103582

510(k) Number K103582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2010
Decision Date April 14, 2011
Days to Decision 127 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
21d faster than avg
Panel avg: 148d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXN Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K103582.
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K122353 · Aesculap, Inc. · Aug 2012
MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION
K082175 · Bioplate, Inc. · Aug 2008
PATIENT CONTOURED MESH-PEEK (PCM-P)
K072707 · KLS-Martin L.P. · Dec 2007
MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K070901 · Bioplate, Inc. · Jun 2007