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Triton Electric High Torque Handpiece and Software Module

by Medtronic Surgical Technologies

510(k) K121264

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121264 Date27 Aug 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HBE
Device Class
Class II
Regulation
21 CFR Part 882.4310
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Triton Electric High Torque Handpiece and Software Module is a powered surgical instrument classified as Drills, Burrs, Trephines & Accessories (Simple, Powered). It provides an electric motor that rotates to drive interchangeable attachments such as saws, drills, and drivers for bone and tissue manipulation in the operating room.

The system includes the handpiece and a software module that monitors and controls handpiece position, torque, and direction. It is a Class II device cleared through a traditional FDA 510(k) submission (K121264) under product code HBE and regulation 882.4310. The device is supplied as a complete unit for use by surgeons in clinical settings and is subject to the applicable FDA clearance requirements.