# K233958: hekaDrill

- Pathway: 510(k) (Traditional)
- Applicant: Zethon, Ltd.
- Decided: Mar 14, 2024 after 90 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- 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)
- K041523: XPS 3000 System, Medtronic Xomed, Inc. (2004) Summary page 4.
- K163565: MR8 Drill System, Medtronic Powered Surgical Solutions (2017) Summary page 4.
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)], Medtronic Xomed, Inc. (2008) Summary page 4.
- K090112: Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700, Medtronic Powered Surgical Solutions (2009) Summary page 4.

## 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, bone and biomaterials. The system is specifically intended for use in Neurosurgical (Cranial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Stemotomy, and General Surgical Procedures.

Source page: https://510kreport.com/device/K233958
Methodology: https://510kreport.com/methodology