Cleared Traditional

K142996 - StaXx(R) XD System

K142996 is an FDA 510(k) clearance for StaXx XD System, manufactured by Spine Wave, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K142996

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.

MQP Device Classification - Class 2, Special Controls

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 259
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K142996.
NuVasive PEEK Corpectomy System
K151167 · Nu Vasive, Incorporated · Sep 2015
SpineFab Vertebral Body Replacement (VBR) System
K142005 · Oxford Performance Materials · Jul 2015
NuVasive X-CORE(R) Expandable VBR System
K142205 · Nuvasive, Inc. · Feb 2015
VERTA Corpectomy Cage
K143490 · Camber Spine · Jan 2015
STGC-LORDOTIC
K142030 · Cardinal Spine, LLC · Jan 2015
CAPRI
K142016 · K2m, Inc. · Nov 2014