Cleared Traditional

OSSDSIGN Cranioplug (K181539) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 13
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
AESCULAP PEEK CRANIOFIX
K091692 · Aesculap, Inc. · Aug 2010
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
K042986 · Synthes (Usa) · Nov 2004