Cleared Traditional

K123299 - MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS

K123299 is an FDA 510(k) clearance for MTS SYSTEM, manufactured by St. Jude Medical Neuromodulation. The device is a Class 2 Neurology device with product code GZB cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K123299 · St. Jude Medical Neuromodulation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
87d
Days
Class 2
Risk

K123299 is an FDA 510(k) clearance for the MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by St. Jude Medical Neuromodulation (Plano, US). The FDA issued a Cleared decision on January 18, 2013 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all St. Jude Medical Neuromodulation devices

FDA 510(k) Submission Details - K123299

510(k) Number K123299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2012
Decision Date January 18, 2013
Days to Decision 87 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZB Device Classification - Class 2, Special Controls

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 Neurology devices follow this clearance model.

Regulatory Peers - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 103
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K123299.
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
K180981 · Stimwave Technologies Incorporated · Sep 2018
SWIFT-LOCK ANCHOR
K140272 · St Jude Medical · May 2014
MULTI LEAD TRIAL CABLE
K130545 · St Jude Medical · Jun 2013
RAPID PROGRAMMER
K113611 · St Jude Medical · Apr 2012
MULTI-LEAD TRIALING CABLE MODEL 355531
K102523 · Medtronic, Inc. · Oct 2010
SWIFT-LOCK ANCHOR, MODEL 1192
K092371 · Advanced Neuromodulation Systems · Dec 2009