Cleared Special

K181306 - Actifuse Flow

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

K181306 · Baxter Healthcare Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K181306

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.

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 K181306.
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K180853 · Elute, Inc. · Aug 2018
JGH1 Core Deccompression Procedure Kit
K181585 · AgNovos Healthcare USA, LLC · Jul 2018
JGH1 Bone Graft Substitute
K181342 · AgNovos Healthcare USA, LLC · Jul 2018
K181306 · Actifuse Flow
Download PDF FDA Summary Baxter Healthcare Cor…