Cleared Special

K251720 - OsteoFlo HydroFiber

K251720 is an FDA 510(k) clearance for OsteoFlo HydroFiber, manufactured by SurGenTec, LLC. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 28-day FDA review.

K251720 · SurGenTec, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
28d
Days
Class 2
Risk

K251720 is an FDA 510(k) clearance for the OsteoFlo HydroFiber. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on July 2, 2025 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K251720

510(k) Number K251720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2025
Decision Date July 02, 2025
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K251720.
Mg OSTEOINJECT™
K251522 · Bone Solutions, Inc. · Oct 2025
Allomatrix (Allomatrix Injectable Putty
K252085 · Wright Medical Technology, Inc. (Stryker Corporation) · Sep 2025
Device 300423 Granules
K251556 · Geistlich Pharma AG · Jul 2025
Grafton™ DBM
K251193 · Medtronic Sofamor Danek, Inc. · Jun 2025
OsteoFlo HydroFiber
K243949 · SurGenTec, LLC · May 2025
MagnetOs MIS
K243474 · Kuros Biosciences B.V · May 2025
K251720 · OsteoFlo HydroFiber
Download PDF FDA Summary SurGenTec, LLC