Cleared Traditional

K253732 - Permatage Flowable, Settable Bone Paste

K253732 is an FDA 510(k) clearance for Permatage Flowable, manufactured by Orthocon, Inc.. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K253732 · Orthocon, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
109d
Days
Class 2
Risk

K253732 is an FDA 510(k) clearance for the Permatage Flowable, Settable Bone Paste. 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 March 13, 2026 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - 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 Orthocon, Inc. devices

FDA 510(k) Submission Details - K253732

510(k) Number K253732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 148d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXP Device Classification - Class 2, Special Controls

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 38
Devices cleared under the same product code (GXP) and FDA review panel - the closest regulatory comparables to K253732.
TnR Cranial Implant
K251959 · T&R BIOFAB CO., Ltd. · Jul 2026
Permatage XT Settable Bone Putty
K261265 · Orthocon, Inc. · Jun 2026
MONTAGE XT Cranial Cement
K253854 · Orthocon, Inc. · Jan 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