Cleared Traditional

K171563 - MagnetOs Putty

K171563 is an FDA 510(k) clearance for MagnetOs Putty, 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 86-day FDA review.

K171563 · Kuros Biosciences B.V · Orthopedic device
Download Printable Device Report (PDF)
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Aug 2017
Decision
86d
Days
Class 2
Risk

K171563 is an FDA 510(k) clearance for the MagnetOs 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 August 24, 2017 after a review of 86 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 Kuros Biosciences B.V devices

FDA 510(k) Submission Details - K171563

510(k) Number K171563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2017
Decision Date August 24, 2017
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 122d · This submission: 86d
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 291
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K171563.
BioSphere MIS Putty (BioSphere MIS)
K173301 · Synergy Biomedical, LLC · Jan 2018
NuVasive AttraX Scaffold
K172497 · Nu Vasive, Incorporated · Nov 2017
Resorbable Mesh Device
K172130 · SeaSpine Orthopedics Corporation · Nov 2017
Vitoss Bioactive (BA) Injectable
K163621 · Orthovita, Inc. · May 2017
NovaBone IRM
K163310 · Novabone Products, LLC · Jan 2017
HydroSet XT
K161447 · Orthovita, Inc. · Oct 2016