Cleared Traditional

K181539 - OSSDSIGN Cranioplug

K181539 is an FDA 510(k) clearance for OSSDSIGN Cranioplug, manufactured by Ossdsign AB. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K181539 · Ossdsign AB · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
123d
Days
Class 2
Risk

K181539 is an FDA 510(k) clearance for the OSSDSIGN Cranioplug. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Ossdsign AB (Uppsala, SE). The FDA issued a Cleared decision on October 12, 2018 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - 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 Ossdsign AB devices

FDA 510(k) Submission Details - K181539

510(k) Number K181539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2018
Decision Date October 12, 2018
Days to Decision 123 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
25d faster than avg
Panel avg: 148d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXR Device Classification - Class 2, Special Controls

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
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 - GXR Cover, Burr Hole

All 16
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K181539.
Absorbable Cranial Flap Fixation System
K221606 · Chendu Medart Medical Scientific Co., Ltd. · Nov 2023
Flap Fixator, Burr Hole Cover
K192310 · Ossaware Biotech Co., Ltd. · Jun 2020
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
K192162 · Neurovention, LLC · Mar 2020
GuardianTM Burr Hole Cover System
K181382 · St Jude Medical · Jul 2018
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
K152342 · St Jude Medical · Jun 2016
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
K130309 · Biomet Microfixation · Jun 2013