Cleared Traditional

K171894 - NuVasive Precept Spinal System

K171894 is the FDA 510(k) clearance for NuVasive Precept Spinal System by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K171894 · Nu Vasive, Incorporated · Orthopedic device
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Sep 2017
Decision
94d
Days
Class 2
Risk

K171894 is an FDA 510(k) clearance for the NuVasive® Precept™ Spinal 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 September 28, 2017 after a review of 94 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 K171894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2017
Decision Date September 28, 2017
Days to Decision 94 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
28d faster than avg
Panel avg: 122d · This submission: 94d
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 K171894.
Solanas® Posterior Stabilization System
K173522 · Alphatec Spine, Inc. · Nov 2017
VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations
K173095 · Medos International SARL · Oct 2017
XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory
K172724 · Stryker Corporation · Oct 2017
ROMEO® 2 Posterior Osteosynthesis System
K172101 · Spineart · Sep 2017
Range/Denali/Mesa Spinal System
K171832 · K2m, Inc. · Sep 2017
Additional VIPER PRIME™ screws with fenestrations
K171570 · Medos International SARL · Aug 2017