Cleared Traditional

K232347 - MagnetOs Granules

K232347 is an FDA 510(k) clearance for MagnetOs Granules, manufactured by Kuros Biosciences B.V. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K232347 · Kuros Biosciences B.V · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
168d
Days
Class 2
Risk

K232347 is an FDA 510(k) clearance for the MagnetOs Granules. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Kuros Biosciences B.V (Bilthoven, NL). The FDA issued a Cleared decision on January 19, 2024 after a review of 168 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 Kuros Biosciences B.V devices

FDA 510(k) Submission Details - K232347

510(k) Number K232347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2023
Decision Date January 19, 2024
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
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 290
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K232347.
Cerament Bone Void Filler
K240459 · Bonesupport AB · Mar 2024
ReBOSSIS
K240453 · Orthorebirth Co., Ltd. · Mar 2024
Mg OSTEOINJECT™
K234013 · Bone Solutions, Inc. · Feb 2024
MagnetOs Putty
K230736 · Kuros Biosciences B.V · Dec 2023
Tactoset® Injectable Bone Substitute
K231968 · Anika Therapeutics, Inc. · Dec 2023
MagnetOs Easypack Putty
K233607 · Kuros Biosciences B.V · Dec 2023