Cleared Special

K253854 - MONTAGE XT Cranial Cement (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253854 · Orthocon, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
30d
Days
Class 2
Risk

K253854 is an FDA 510(k) clearance for the MONTAGE XT Cranial Cement. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Orthocon, Inc. (Stamford, US). The FDA issued a Cleared decision on January 2, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orthocon, Inc. devices

Submission Details

510(k) Number K253854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2025
Decision Date January 02, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GXP Methyl Methacrylate For Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5300
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 - GXP Methyl Methacrylate For Cranioplasty

All 42
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K253854.
Permatage Flowable, Settable Bone Paste
K253732 · Orthocon, Inc. · Mar 2026
Permatage Settable Bone Putty
K241027 · Orthocon, Inc. · Sep 2024
Montage Flowable Settable, Resorbable Bone Paste
K232771 · Orthocon, Inc. · Feb 2024
MONTAGE-QS Settable, Resorbable Bone Putty
K231475 · Orthocon, Inc. · Oct 2023
MONTAGE Settable, Resorbable Bone Putty
K221933 · Orthocon, Inc. · Jan 2023