Cleared Traditional

K180179 - Firebird Spinal Fixation Systems: Fireb...

Also marketed or referenced as:
Firebird Deformity System Firebird® NXG Spinal Fixation System Phoenix® Minimally Invasive Spinal Fixation System Phoenix® CDX™ Minimally Invasive Spinal Fixation System JANUS® Midline Fixation Screw JANUS® Fenestrated Screw

K180179 is the FDA 510(k) clearance for Firebird Spinal Fixation Systems: Fireb... by Orthofix, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K180179 · Orthofix, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
213d
Days
Class 2
Risk

K180179 is an FDA 510(k) clearance for the Firebird® Spinal Fixation Systems: Firebird System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Orthofix, Inc. (Lewisville, US). The FDA issued a Cleared decision on August 24, 2018 after a review of 213 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Orthofix, Inc. devices

Submission Details

510(k) Number K180179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2018
Decision Date August 24, 2018
Days to Decision 213 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
91d slower than avg
Panel avg: 122d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To 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 - NKB Thoracolumbosacral Pedicle Screw System

All 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K180179.
Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
K181390 · OrthoPediatrics Corp. · Sep 2018
MOSS VRS Spinal System
K181821 · Biedermann Motech GmbH & Co. KG · Sep 2018
CD HORIZON™ Spinal System
K182119 · Medtronic Sofamor Danek USA, Inc. · Aug 2018
Zenius™, Iliad™ and Kora™ Spinal Fixation Systems
K181978 · Medyssey USA, Inc. · Aug 2018
Redi-Spine
K181584 · Innovative Surgical Designs, Inc. · Aug 2018
Kodiak Spinal Fixation System
K181677 · Alphatec Spine, Inc. · Aug 2018