Cleared Traditional

K222063 - MONTAGE Settable, Resorbable Bone Putty

K222063 is an FDA 510(k) clearance for MONTAGE 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 205-day FDA review.

K222063 · Orthocon, Inc. · Orthopedic device
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Feb 2023
Decision
205d
Days
Class 2
Risk

K222063 is an FDA 510(k) clearance for the MONTAGE Settable, Resorbable Bone Putty. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on February 3, 2023 after a review of 205 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 - K222063

510(k) Number K222063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2022
Decision Date February 03, 2023
Days to Decision 205 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
83d slower than avg
Panel avg: 122d · This submission: 205d
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 403
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K222063.
Tactoset
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DSM Biomedical Calcium Phosphate Cement
K230054 · Dsm Biomedical · Mar 2023
GaiaBone Bioabsorbable Bone Graft
K220337 · Corliber (Shenzhen) Medical Device Co., Ltd. · Feb 2023
OsteoCNX
K223563 · Converg Engineering · Jan 2023
Uni-FuZe-C Bone Strip
K221726 · Zavation Medical Products, LLC · Jan 2023
Mineral Collagen Composite Bioactive Moldable
K221735 · Collagen Matrix, Inc. · Dec 2022