Cleared Traditional

K141186 - FIREBIRD SPINAL FIXATION SYSTEM

K141186 is an FDA 510(k) clearance for FIREBIRD SPINAL FIXATION SYSTEM, manufactured by Orthofix, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K141186 · Orthofix, Inc. · Orthopedic device
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Jan 2015
Decision
240d
Days
Class 2
Risk

K141186 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 January 2, 2015 after a review of 240 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

FDA 510(k) Submission Details - K141186

510(k) Number K141186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2014
Decision Date January 02, 2015
Days to Decision 240 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
118d slower than avg
Panel avg: 122d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 875
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K141186.
PASS LP SPINAL SYSTEM
K141398 · Medicrea International SA · Jan 2015
Range/Denali/Mesa Spinal System
K143334 · K2m, Inc. · Jan 2015
Arsenal Spinal Fixation System
K143149 · Alphatec Spine, Inc. · Jan 2015
ACROSSPINE PEDICLE SCREW SYSTEM
K141695 · Arthro-Dif · Dec 2014
Reform Pedicle Screw System
K143248 · Precision Spine, Inc. · Dec 2014
MAS PLIF Fixation system
K142737 · Nu Vasive, Incorporated · Dec 2014