Cleared Special

K181306 - Actifuse Flow

K181306 is the FDA 510(k) clearance for Actifuse Flow by Baxter Healthcare Corporation. It is a Class 2 Orthopedic device (product code MQV) cleared through the Special 510(k) pathway after a 92-day FDA review.

K181306 · Baxter Healthcare Corporation · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2018
Decision
92d
Days
Class 2
Risk

K181306 is an FDA 510(k) clearance for the Actifuse Flow. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on August 17, 2018 after a review of 92 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Baxter Healthcare Corporation devices

Submission Details

510(k) Number K181306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2018
Decision Date August 17, 2018
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

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 232
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