Cleared Traditional

Falco Fusion System

K253611 · Mcnicoll Surgical, Inc. · Orthopedic

Jan 2026

Decision

72d

Days

Class 2

Risk

About This 510(k) Submission

K253611 is an FDA 510(k) clearance for the Falco Fusion System, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by Mcnicoll Surgical, Inc. (Quebec City, CA). The FDA issued a Cleared decision on January 29, 2026, 72 days after receiving the submission on November 18, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K253611 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 2025
Decision Date	January 29, 2026
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF