Cleared Special

K203138 - FIREBIRD SI Fusion System

K203138 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 29-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

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 K203138.
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
K210035 · Aegis Spine · Feb 2021
Advanced Research Medical Trident SI Screw System
K203373 · Advanced Research Medical, LLC · Jan 2021
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K203671 · Medacta International S.A. · Jan 2021
Life Spine SIMPACT Sacroiliac Joint Fixation System
K201538 · Life Spine, Inc. · Sep 2020
FIREBIRD SI Fusion System
K201664 · Orthofix, Inc. · Sep 2020
NADIA SI Fusion System
K190580 · Ilion Medical, Inc. · Aug 2020