Cleared Special

K130176 - FIREBIRD SPINAL FIXATION SYSTEM

K130176 is an FDA 510(k) clearance for FIREBIRD SPINAL FIXATION SYSTEM, manufactured by Orthofix. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 62-day FDA review.

K130176 · Orthofix · Orthopedic device
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Mar 2013
Decision
62d
Days
Class 2
Risk

K130176 is an FDA 510(k) clearance for the FIREBIRD SPINAL FIXATION 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 (Lewisville, US). The FDA issued a Cleared decision on March 28, 2013 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 devices

FDA 510(k) Submission Details - K130176

510(k) Number K130176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2013
Decision Date March 28, 2013
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

NKB Device Classification - Class 2, Special Controls

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 733
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K130176.
S4 SPINAL SYSTEM
K130291 · Aesculap Implant System, Inc. · Apr 2013
CD HORIZON SPINAL SYSTEM
K130646 · Medtronic Sofamor Danek USA, Inc. · Apr 2013
STREAMLINE MIS SPINAL FIXATION SYSTEM
K130286 · Pioneer Surgical Technology, Inc. · Apr 2013
S4 SPINAL SYSTEM
K123939 · Aesculap Implant Systems, Inc. · Mar 2013
NAUTILUS SPINAL SYSTEM
K123373 · Life Spine · Mar 2013
UCENTUM
K123717 · Ulrich GmbH & Co. KG · Mar 2013