Cleared Traditional

K130932 - FIREBIRD SPINAL FIXATION SYSTEM

K130932 is the FDA 510(k) clearance for FIREBIRD SPINAL FIXATION SYSTEM by Orthofix, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K130932 · Orthofix, Inc. · Orthopedic device
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Aug 2013
Decision
125d
Days
Class 2
Risk

K130932 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, Inc. (Lewisville, US). The FDA issued a Cleared decision on August 7, 2013 after a review of 125 days - within the typical 510(k) review window.

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 K130932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2013
Decision Date August 07, 2013
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
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 K130932.
TIGER SPINE SYSTEM
K131250 · Corelink, LLC · Sep 2013
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
K131980 · Zimmer Spine, Inc. · Sep 2013
PAGODA PEDICLE SCREW SYSTEM
K131785 · Ortho Development Corp. · Aug 2013
EXPEDIUM SPINE SYSTEM
K130877 · Medos International SARL · Jun 2013
SOLANAS POSTERIOR STABILIZATION SYSTEM
K131119 · Alphatec Spine, Inc. · May 2013
CD HORIZON SPINAL SYSTEM
K130646 · Medtronic Sofamor Danek USA, Inc. · Apr 2013