Cleared Traditional

K142996 - StaXx XD System

K142996 is the FDA 510(k) clearance for StaXx XD System by Spine Wave, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K142996 · Spine Wave, Inc. · Orthopedic device
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Feb 2015
Decision
126d
Days
Class 2
Risk

K142996 is an FDA 510(k) clearance for the StaXx(R) XD System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on February 19, 2015 after a review of 126 days - within the typical 510(k) review window.

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 Spine Wave, Inc. devices

Submission Details

510(k) Number K142996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2014
Decision Date February 19, 2015
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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 K142996.
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K142205 · Nuvasive, Inc. · Feb 2015
CAPRI
K142016 · K2m, Inc. · Nov 2014
LATERAL VBR SYSTEM
K140563 · Nu Vasive, Incorporated · Aug 2014
STAXX(R) SYSTEM
K133207 · Spine Wave, Inc. · Dec 2013