Cleared Traditional

Permatage Flowable, Settable Bone Paste

K253732 · Orthocon, Inc. · Neurology
Mar 2026
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K253732 is an FDA 510(k) clearance for the Permatage Flowable, Settable Bone Paste, 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 March 13, 2026, 109 days after receiving the submission on November 24, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5300.

Submission Details

510(k) Number K253732 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2025
Decision Date March 13, 2026
Days to Decision 109 days
Submission Type Traditional
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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