# K121264: Triton Electric High Torque Handpiece and Software Module

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Surgical Technologies
- Decided: Aug 27, 2012 after 123 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K862807 (1986). 59 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)], Medtronic Xomed, Inc. (2008) Summary page 2.
- K081277: XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc), Medtronic Xomed, Inc. (2008) Summary page 2.
- K111520: Ipc Powerease System, Medtronic Xomed, Inc. (2011) Summary page 2.

## Most influential descendants
- K170312: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools (2017), 11 descendants of its own
- K191597: Stealth Autoguide System, Midas Rex Legend Depth Stop System (2019), 4 descendants of its own
- K183515: MR8 Drill System, Midas Rex MR8 ClearView Tools (2019), 4 descendants of its own
- K183644: Stealth-Midas MR8 System (2019), 3 descendants of its own
- K210989: Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System (2021), 2 descendants of its own

## Indications for use
The IPO System with the TRITON Electric High-Torque Handpiece is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

Source page: https://510kreport.com/device/K121264
Methodology: https://510kreport.com/methodology