Cleared Traditional

K170126 - NuVasive Reline 4.5-5.0 System

K170126 is the FDA 510(k) clearance for NuVasive Reline 4.5-5.0 System by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K170126 · Nu Vasive, Incorporated · Orthopedic device
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Mar 2017
Decision
55d
Days
Class 2
Risk

K170126 is an FDA 510(k) clearance for the NuVasive® Reline® 4.5-5.0 System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on March 9, 2017 after a review of 55 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nu Vasive, Incorporated devices

Submission Details

510(k) Number K170126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2017
Decision Date March 09, 2017
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K170126.
Fortress™ Pedicular Fixation System
K170268 · Spineology, Inc. · Apr 2017
USS System
K170654 · Synthes USA Products, LLC · Mar 2017
SeaSpine® Daytona® Small Stature Spinal System
K163604 · SeaSpine Orthopedics Corporation · Mar 2017
CD HORIZON® Spinal System
K163301 · Medtronic Sofamor Danek USA, Inc. · Dec 2016
VIPER PRIME™ additions to the VIPER® System
K162912 · Medos International SARL · Dec 2016
CD HORIZON® Spinal System
K162379 · Medtronic Sofamor Danek USA, Inc. · Nov 2016