Cleared Traditional

K121264 - TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE

K121264 is an FDA 510(k) clearance for TRITON ELECTRIC HIGH TORQUE HANDPIECE A..., manufactured by Medtronic Surgical Technologies. The device is a Class 2 Neurology device with product code HBE cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K121264 · Medtronic Surgical Technologies · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
123d
Days
Class 2
Risk

K121264 is an FDA 510(k) clearance for the TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Medtronic Surgical Technologies (Fort Worth, US). The FDA issued a Cleared decision on August 27, 2012 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Surgical Technologies devices

FDA 510(k) Submission Details - K121264

510(k) Number K121264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2012
Decision Date August 27, 2012
Days to Decision 123 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
25d faster than avg
Panel avg: 148d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBE Device Classification - Class 2, Special Controls

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
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 - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 50
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K121264.
HICUT HIGHSPEED INSTRUMENT
K130755 · Adeor Medical AG · Jun 2014
VARIOGUIDE DRILL KIT
K132436 · Mri Interventions, Inc. · Mar 2014
POWEREASE SYSTEM
K123270 · Medtronic Sofamor Danek USA, Inc. · Jan 2013
ANSPACH DISSECTION TOOLS
K113476 · The Anspach Effort, Inc. · Dec 2011
IPC POWEREASE SYSTEM
K111520 · Medtronic Xomed, Inc. · Oct 2011
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
K081475 · Medtronic Xomed, Inc. · Oct 2008