# K012457: Sodem High Speed System (Electric) (Neuro/Spine Surgery)

- Pathway: 510(k) (Traditional)
- Applicant: Sodemsystems
- Decided: Oct 22, 2001 after 82 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: 5 generations back to K862807 (1986). 18 ancestors in all.
447 later devices descend from it; 4 cite it directly.
1 of 466 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943541: 75K Staight Drill, Stryker Corp. (1995) Summary page 1.
- K990524: E9000 System, Linvatec Corp. (1999) Summary page 1.
- K002523: Advantage Drive System, Linvatec Corp. (2000) Summary page 1.

## Most influential descendants
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] (2008), 443 descendants of its own
- K081277: XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) (2008), 420 descendants of its own
- K111520: Ipc Powerease System (2011), 418 descendants of its own
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps (2013), 404 descendants of its own
- K123270: Powerease System (2013), 398 descendants of its own

## Indications for use
The Sodem High Speed motor allows the fixation of spindles and craniotomes, which operate with drills, burs and cutters for drilling, cutting and sculpting the cranial and spinal bones. The Sodem High Speed System (Electric) includes a skull perforator motor, which powers a cranial perforation attachment and allows skull perforation. The System does not include the cranial perforation attachment. The safety of the skull perforation depends exclusively on the safety of the cranial perforation attachment, which is neither manufactured nor sold by Sodem, but is available on the market from other manufacturers. Both motors, attachments and cutting tools are for use in neurosurgery, as well craniotomy as spinal surgery.

Source page: https://510kreport.com/device/K012457
Methodology: https://510kreport.com/methodology