Cleared Traditional

K142205 - NuVasive X-CORE Expandable VBR System

K142205 is the FDA 510(k) clearance for NuVasive X-CORE Expandable VBR System by Nuvasive, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K142205 · Nuvasive, Inc. · Orthopedic device
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Feb 2015
Decision
193d
Days
Class 2
Risk

K142205 is an FDA 510(k) clearance for the NuVasive X-CORE(R) Expandable VBR System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on February 20, 2015 after a review of 193 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Nuvasive, Inc. devices

Submission Details

510(k) Number K142205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2014
Decision Date February 20, 2015
Days to Decision 193 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
71d slower than avg
Panel avg: 122d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K142205.
NuVasive(r) Monolith Corpectomy System
K170271 · Nu Vasive, Incorporated · Mar 2017
NuVasive PEEK Corpectomy Railed System
K151538 · Nu Vasive, Incorporated · Sep 2015
NuVasive PEEK Corpectomy System
K151167 · Nu Vasive, Incorporated · Sep 2015
StaXx(R) XD System
K142996 · Spine Wave, Inc. · Feb 2015
CAPRI
K142016 · K2m, Inc. · Nov 2014
LATERAL VBR SYSTEM
K140563 · Nu Vasive, Incorporated · Aug 2014