Cleared Special

K200696 - FIREBIRD SI Fusion System

K200696 is the FDA 510(k) clearance for FIREBIRD SI Fusion System by Orthofix, Inc.. It is a Class 2 Orthopedic device (product code OUR) cleared through the Special 510(k) pathway after a 16-day FDA review.

K200696 · Orthofix, Inc. · Orthopedic device
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Apr 2020
Decision
16d
Days
Class 2
Risk

K200696 is an FDA 510(k) clearance for the FIREBIRD SI Fusion System. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Orthofix, Inc. (Lewisville, US). The FDA issued a Cleared decision on April 2, 2020 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orthofix, Inc. devices

Submission Details

510(k) Number K200696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2020
Decision Date April 02, 2020
Days to Decision 16 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
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion
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 - OUR Sacroiliac Joint Fixation

All 105
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K200696.
FIREBIRD SI Fusion System
K201664 · Orthofix, Inc. · Sep 2020
NADIA SI Fusion System
K190580 · Ilion Medical, Inc. · Aug 2020
SI-Restore Sacroiliac Joint Fixation System
K200868 · Biofusion Medical · Apr 2020
SI-BONE iFuse Implant System®
K193524 · SI-BONE, Inc. · Mar 2020
M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
K193083 · Medacta International S.A. · Dec 2019
Genesys Spine Sacroiliac Joint Fusion System
K191748 · Genesys Spine · Sep 2019