Cleared Traditional

K221933 - MONTAGE Settable, Resorbable Bone Putty

K221933 is an FDA 510(k) clearance for MONTAGE 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 196-day FDA review.

K221933 · Orthocon, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
196d
Days
Class 2
Risk

K221933 is an FDA 510(k) clearance for the MONTAGE Settable, Resorbable Bone Putty. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on January 13, 2023 after a review of 196 days - an extended review cycle.

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 - K221933

510(k) Number K221933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2022
Decision Date January 13, 2023
Days to Decision 196 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
48d slower than avg
Panel avg: 148d · This submission: 196d
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 K221933.
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
DB-CMF
K182742 · Dimensional Bioceramics, LLC · Jun 2019
OsteoVation Impact
K162864 · Skeletal Kinetics, LLC · Jan 2017
DirectInject
K143661 · Stryker · Sep 2015