Cleared Special

K203138 - FIREBIRD SI Fusion System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K203138 · Orthofix, Inc. · Orthopedic device

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Nov 2020

Decision

29d

Days

Class 2

Risk

K203138 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 November 18, 2020 after a review of 29 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	K203138 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 20, 2020
Decision Date	November 18, 2020
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

93d faster than avg

Panel avg: 122d · This submission: 29d

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.