Cleared Traditional

K233566 - Montage-XT Settable, Resorbable Bone Putty

K233566 is an FDA 510(k) clearance for Montage-XT Settable, manufactured by Orthocon, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K233566 · Orthocon, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
289d
Days
Class 2
Risk

K233566 is an FDA 510(k) clearance for the Montage-XT Settable, Resorbable Bone Putty. 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 August 21, 2024 after a review of 289 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Orthocon, Inc. devices

FDA 510(k) Submission Details - K233566

510(k) Number K233566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2023
Decision Date August 21, 2024
Days to Decision 289 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 122d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQV Device Classification - Class 2, Special Controls

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 Peers - MQV Filler, Bone Void, Calcium Compound

All 398
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K233566.
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