Cleared Special

K243526 - MONTAGE Settable

K243526 is the FDA 510(k) clearance for MONTAGE Settable by Orthocon, Inc.. It is a Class 2 Orthopedic device (product code MQV) cleared through the Special 510(k) pathway after a 21-day FDA review.

K243526 · Orthocon, Inc. · Orthopedic device
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Dec 2024
Decision
21d
Days
Class 2
Risk

K243526 is an FDA 510(k) clearance for the MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone.... Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Orthocon, Inc. (Stamford, US). The FDA issued a Cleared decision on December 5, 2024 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orthocon, Inc. devices

Submission Details

510(k) Number K243526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2024
Decision Date December 05, 2024
Days to Decision 21 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 Orthopedic devices follow this clearance model.

Regulatory Consultant

Mcra, LLC
Mehdi Kazemzadeh-Narbat

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQV Filler, Bone Void, Calcium Compound

All 230
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K243526.
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