Cleared Traditional

K231475 - MONTAGE-QS Settable, Resorbable Bone Putty

K231475 is an FDA 510(k) clearance for MONTAGE-QS Settable, 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 143-day FDA review.

K231475 · Orthocon, Inc. · Neurology device
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Oct 2023
Decision
143d
Days
Class 2
Risk

K231475 is an FDA 510(k) clearance for the MONTAGE-QS Settable, Resorbable Bone Putty. 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 October 12, 2023 after a review of 143 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 - K231475

510(k) Number K231475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2023
Decision Date October 12, 2023
Days to Decision 143 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 148d · This submission: 143d
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 K231475.
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 Settable, Resorbable Bone Putty
K221933 · Orthocon, Inc. · Jan 2023
DB-CMF
K182742 · Dimensional Bioceramics, LLC · Jun 2019
OsteoVation Impact
K162864 · Skeletal Kinetics, LLC · Jan 2017