Cleared Traditional

K201664 - FIREBIRD SI Fusion System

K201664 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 Traditional 510(k) pathway after a 88-day FDA review.

K201664 · Orthofix, Inc. · Orthopedic device
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Sep 2020
Decision
88d
Days
Class 2
Risk

K201664 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 September 15, 2020 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthofix, Inc. devices

Submission Details

510(k) Number K201664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2020
Decision Date September 15, 2020
Days to Decision 88 days
Submission Type Traditional
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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K201664.
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K203671 · Medacta International S.A. · Jan 2021
FIREBIRD SI Fusion System
K203138 · Orthofix, Inc. · Nov 2020
Life Spine SIMPACT Sacroiliac Joint Fixation System
K201538 · Life Spine, Inc. · Sep 2020
NADIA SI Fusion System
K190580 · Ilion Medical, Inc. · Aug 2020
SI-Restore Sacroiliac Joint Fixation System
K200868 · Biofusion Medical · Apr 2020
FIREBIRD SI Fusion System
K200696 · Orthofix, Inc. · Apr 2020