Cleared Special

K210667 - FIREBIRD SI Fusion System

K210667 is an FDA 510(k) clearance for FIREBIRD SI Fusion System, manufactured by Orthofix, Inc.. The device is a Class 2 Orthopedic device with product code OUR cleared through the Special 510(k) pathway after a 20-day FDA review.

K210667 · Orthofix, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
20d
Days
Class 2
Risk

K210667 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 March 25, 2021 after a review of 20 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.

FDA 510(k) Submission Details - K210667

510(k) Number K210667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2021
Decision Date March 25, 2021
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

OUR Device Classification - Class 2, Special Controls

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 132
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K210667.
SIMPACT Sacroiliac Joint Fixation System
K212903 · Life Spine, Inc. · Dec 2021
Curiteva Sacroiliac Joint Fusion System
K210402 · Curiteva, Inc. · Sep 2021
Triton™ Sacroiliac Joint Fixation System
K211449 · Choice Spine, LLC · Aug 2021
Harvester SI: Sacroiliac Fixation System
K203780 · Spinus International, Inc. · Mar 2021
iFuse-TORQ™ Implant System
K203247 · SI-BONE, Inc. · Feb 2021
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
K210035 · Aegis Spine · Feb 2021
K210667 · FIREBIRD SI Fusion System
Download PDF FDA Summary Orthofix, Inc.