Cleared Traditional

CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM (K101235) - FDA 510(k) Clearance

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

K101235 · Neos Surgery S.L · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
175d
Days
Class 2
Risk

K101235 is an FDA 510(k) clearance for the CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Neos Surgery S.L (Alexandria, US). The FDA issued a Cleared decision on October 25, 2010 after a review of 175 days - an extended review cycle.

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 Neos Surgery S.L devices

Submission Details

510(k) Number K101235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2010
Decision Date October 25, 2010
Days to Decision 175 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
27d slower than avg
Panel avg: 148d · This submission: 175d
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 14
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K101235.
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
K192162 · Neurovention, LLC · Mar 2020
OSSDSIGN Cranioplug
K181539 · Ossdsign AB · Oct 2018
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
SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP
K041611 · Synthes (Usa) · Sep 2004