Cleared Traditional

K160989 - NuVasive® Reline® System

K160989 is an FDA 510(k) clearance for NuVasive Reline System, manufactured by Nu Vasive, Incorporated. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K160989 · Nu Vasive, Incorporated · Orthopedic device
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Jun 2016
Decision
62d
Days
Class 2
Risk

K160989 is an FDA 510(k) clearance for the NuVasive® Reline® 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 June 9, 2016 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. 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

FDA 510(k) Submission Details - K160989

510(k) Number K160989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2016
Decision Date June 09, 2016
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
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 888
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K160989.
PressON Pro Spinal Fixation System
K160820 · Nexus Spine, LLC · Jun 2016
F1 MPS Modular Pedicle Screw System
K160926 · Degen Medical · Jun 2016
Arsenal Spinal Fixation System
K161363 · Alphatec Spine, Inc. · Jun 2016
Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
K160775 · Choicespine, LP · Jun 2016
Mariner Pedicle Screw System
K160902 · SeaSpine Orthopedics Corporation · May 2016
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
K160980 · Spineology, Inc. · May 2016