Cleared Traditional

K161859 - MagnetOs

K161859 is an FDA 510(k) clearance for MagnetOs, manufactured by Xpand Biotechnology BV. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K161859 · Xpand Biotechnology BV · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
233d
Days
Class 2
Risk

K161859 is an FDA 510(k) clearance for the MagnetOs. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Xpand Biotechnology BV (Bilthoven, NL). The FDA issued a Cleared decision on February 24, 2017 after a review of 233 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.

FDA 510(k) Submission Details - K161859

510(k) Number K161859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2016
Decision Date February 24, 2017
Days to Decision 233 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
111d slower than avg
Panel avg: 122d · This submission: 233d
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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K161859.
FIBERGRAFT BG Putty Bone Graft Substitute
K170306 · Prosidyan, Inc. · May 2017
Vitoss Bioactive (BA) Injectable
K163621 · Orthovita, Inc. · May 2017
NovoGro
K162087 · Osteonovus, Inc. · Apr 2017
0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE
K161996 · Amend Surgical, Inc. · Feb 2017
MCS Bone Graft
K162860 · Bioventus, LLC · Feb 2017
NovaBone IRM
K163310 · Novabone Products, LLC · Jan 2017
K161859 · MagnetOs
Download PDF FDA Summary Xpand Biotechnology BV