# K193630: hekaDrill

- Pathway: 510(k) (Traditional)
- Applicant: Zethon, Ltd.
- Decided: Apr 9, 2021 after 470 days
- Product code: HBC (Motor, Drill, Electric)
- Device class: 2
- Regulation: 21 CFR 882.4360
- 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). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 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 5.
- K163565: MR8 Drill System, Medtronic Powered Surgical Solutions (2017) Summary page 5.
- K090112: Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700, Medtronic Powered Surgical Solutions (2009) Summary page 5.
- K020069: Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System, Medtronic Midas Rex (2002) Summary page 5.

## Indications for use
The hekaDrill system is intended for use in surgical procedures involving incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone. The system is specifically intended for use in neurologic and general surgical procedures.

Source page: https://510kreport.com/device/K193630
Methodology: https://510kreport.com/methodology