Cleared Traditional

MagnetOs Granules (K232347) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232347 · Kuros Biosciences B.V · Orthopedic device
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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

Submission Details

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.

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 201
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