Cleared Special

MONTAGE XT Cranial Cement

K253854 · Orthocon, Inc. · Neurology
Jan 2026
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K253854 is an FDA 510(k) clearance for the MONTAGE XT Cranial Cement, a Methyl Methacrylate For Cranioplasty (Class II — Special Controls, product code GXP), submitted by Orthocon, Inc. (Stamford, US). The FDA issued a Cleared decision on January 2, 2026, 30 days after receiving the submission on December 3, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5300.

Submission Details

510(k) Number K253854 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GXP — Methyl Methacrylate For Cranioplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5300

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