# K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)]

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Oct 17, 2008 after 143 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K862807 (1986). 26 ancestors in all.
443 later devices descend from it; 11 cite it directly.
1 of 470 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073255: XPS 3000 System, Medtronic Xomed, Inc. (2008) Summary page 1.
- K935567: Sodem Power System, Sodemsystems (1994) Summary page 1.
- K012453: Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery), Sodemsystems (2001) Summary page 1.
- K012456: Sodem High Speed System (Electric) (Ear, Nose, and Throat), Sodemsystems (2001) Summary page 1.
- K012457: Sodem High Speed System (Electric) (Neuro/Spine Surgery), Sodemsystems (2001) Summary page 1.
- K002523: Advantage Drive System, Linvatec Corp. (2000) Summary page 1.

## Most influential descendants
- 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
- K140454: Navigated CD Horizon Solera Screwdriver/Taps (2014), 396 descendants of its own
- K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter (2013), 246 descendants of its own

## Recalls of this device
- Dec 15, 2021 · Class II · Z-0961-2022: As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a d
- Aug 31, 2021 · Class II · Z-0158-2022: There was an increase in complaints related to tip breaks and wobble/vibration.
- May 13, 2016 · Class II · Z-2085-2016: Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.

## Indications for use
The Electric Drill System 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/K081475
Methodology: https://510kreport.com/methodology