Cleared Traditional

K182974 - NuVasive Reline System

K182974 is the FDA 510(k) clearance for NuVasive Reline System by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K182974 · Nu Vasive, Incorporated · Orthopedic device
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Feb 2019
Decision
110d
Days
Class 2
Risk

K182974 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 February 13, 2019 after a review of 110 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 Nu Vasive, Incorporated devices

Submission Details

510(k) Number K182974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2018
Decision Date February 13, 2019
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
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 K182974.
EUROPA Pedicle Screw System
K180337 · MiRus, LLC · Mar 2019
Modular Spinal Fixation System
K183430 · Life Spine, Inc. · Mar 2019
ISS-JAZZ Screw System and JAZZ CAP SP
K182771 · Implanet, S.A. · Mar 2019
Pedimax II - Pedicular Screw Spinal System
K180626 · Gm Dos Reis Industria E Comerico Ltda. · Feb 2019
EUROPA™ Pedicle Screw System
K182970 · MiRus, LLC · Jan 2019
Whistler Modular Pedicle Screw System
K182478 · Evolution Spine, LLC · Jan 2019