Cleared Traditional

K243949 - OsteoFlo HydroFiber

K243949 is the FDA 510(k) clearance for OsteoFlo HydroFiber by SurGenTec, LLC. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K243949 · SurGenTec, LLC · Orthopedic device
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May 2025
Decision
156d
Days
Class 2
Risk

K243949 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 May 28, 2025 after a review of 156 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 SurGenTec, LLC devices

Submission Details

510(k) Number K243949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2024
Decision Date May 28, 2025
Days to Decision 156 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
34d slower than avg
Panel avg: 122d · This submission: 156d
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 230
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K243949.
Device 300423 Granules
K251556 · Geistlich Pharma AG · Jul 2025
OsteoFlo HydroFiber
K251720 · SurGenTec, LLC · Jul 2025
Grafton™ DBM
K251193 · Medtronic Sofamor Danek, Inc. · Jun 2025
MagnetOs MIS
K243474 · Kuros Biosciences B.V · May 2025
Synthecure Synthetic Calcium Sulfate
K250141 · Austin Medical Ventures, Inc. · May 2025
NanoBone® SBX Putty
K250521 · Biocomposites, Ltd. · Apr 2025