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Falco Fusion System

by Mcnicoll Surgical, Inc.

510(k) K253611

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253611 Date29 Jan 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OUR
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Falco Fusion System is a sacroiliac joint fusion device designed for orthopedic use, consisting of cannulated, fully threaded, fenestrated titanium alloy screws (11mm and 13mm diameters; 35mm–75mm lengths) and associated surgical instruments. It is intended to stabilize or fuse the sacroiliac joint through minimally invasive techniques, incorporating self-drilling and self-tapping screw technology for enhanced osseointegration.

The system includes reusable surgical instruments and disposable Kirschner wires, supplied sterile for single-use procedures. It is approved under FDA 510(k) clearance (K253611) as a substantially equivalent orthopedic device, adhering to traditional review standards. Compatibility with MRI is not specified, and storage conditions must align with manufacturer guidelines to maintain sterility and functionality.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Falco Fusion System used for?

    The Falco Fusion System is designed to stabilize or fuse the sacroiliac joint through minimally invasive techniques, utilizing self-drilling and self-tapping titanium alloy screws for enhanced osseointegration.

  • What sizes and models are available in the Falco Fusion System?

    The system includes cannulated, fully threaded, fenestrated titanium alloy screws in 11mm and 13mm diameters with lengths ranging from 35mm to 75mm.

  • How are the components of the Falco Fusion System supplied?

    The system includes reusable surgical instruments and disposable Kirschner wires, all supplied sterile for single-use procedures to maintain sterility and functionality.

  • What is the regulatory status of the Falco Fusion System?

    The Falco Fusion System has received FDA 510(k) clearance (K253611) as a substantially equivalent orthopedic device under traditional review standards.

  • Are there any special storage requirements for the Falco Fusion System?

    Storage conditions must align with manufacturer guidelines to maintain sterility and functionality of the device, though specific conditions are not detailed in the provided information.