Cleared Traditional

K231903 - Montage-QS Settable

K231903 is the FDA 510(k) clearance for Montage-QS Settable by Orthocon, Inc.. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K231903 · Orthocon, Inc. · Orthopedic device
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Aug 2023
Decision
58d
Days
Class 2
Risk

K231903 is an FDA 510(k) clearance for the Montage-QS 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 25, 2023 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthocon, Inc. devices

Submission Details

510(k) Number K231903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2023
Decision Date August 25, 2023
Days to Decision 58 days
Submission Type Traditional
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
64d faster than avg
Panel avg: 122d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - MQV Filler, Bone Void, Calcium Compound

All 231
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K231903.
Catalyst Bone Void Filler
K232315 · Ossdsign AB · Sep 2023
Cove Putty, OsteoCove Putty
K231030 · SeaSpine Orthopedics Corporation · Sep 2023
Montage Flowable Settable, Resorbable Bone Paste
K231270 · Orthocon, Inc. · Sep 2023
Cove Strip
K230486 · SeaSpine Orthopedics Corporation · Aug 2023
Mineral Collagen Composite Bioactive Extra Moldable
K231942 · Collagen Matrix, Inc. · Aug 2023
Graftys Quickset
K231714 · Graftys · Jul 2023