Cleared Traditional

MagnetOs Easypack Putty (K211201) - FDA 510(k) Clearance

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

K211201 · Kuros Biosciences B.V · Orthopedic device
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Sep 2021
Decision
133d
Days
Class 2
Risk

K211201 is an FDA 510(k) clearance for the MagnetOs Easypack Putty. 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 September 2, 2021 after a review of 133 days - within the typical 510(k) review window.

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 K211201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2021
Decision Date September 02, 2021
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
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 Consultant

Compliance Solutions, Ltd.
Angela Paterson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K211201.
ABCcolla Bone Matrix
K212156 · Acro Biomedical Co., Ltd. · Oct 2021
Dry DBM- A Putty
K212135 · Seaspine Corporation · Oct 2021
DB-EZ Bone Void Filler
K212353 · Dimensional Bioceramics, LLC · Sep 2021
Tactoset Injectable Bone Substitute
K212083 · Anika Therapeutics, Inc. · Aug 2021
CaP Spheres Pellet Pack
K203218 · Zimmer Biomet Spine, Inc. · May 2021
si-Mochi
K202639 · Biostone, Ltd. · Apr 2021