# K111520: Ipc Powerease System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Oct 26, 2011 after 146 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K862807 (1986). 58 ancestors in all.
418 later devices descend from it; 12 cite it directly.
1 of 477 devices in its family (counting itself) has 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 1.
- K063305: Stimulating Bur Guard, Medtronic Xomed, Inc. (2006) Summary page 2.
- K061113: Orthomon, Axon Systems, Inc. (2006) Summary page 1.
- K061639: Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and Vascular Doppler; Cardiomon, Axon Systems, Inc. (2006) Summary page 1.
- K081277: XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc), Medtronic Xomed, Inc. (2008) Summary page 2.
- (no number) Stryker Consolidated Operating Room Equipment (CORE) System: named in the summary without a submission number

## Most influential descendants
- 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
- K150231: Navigated Disc Prep Instruments and CAPSTONE Trials (2015), 242 descendants of its own

## Recalls of this device
- Jul 17, 2025 · Class II · Z-2461-2025: Due to out of the box wobble of the driver.
- Dec 3, 2014 · Class II · Z-0952-2015: The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

## Indications for use
The IPC® 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. The IPC® POWEREASE TM System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in the placement of screws, or cutting of screws, posts, and rods.

Source page: https://510kreport.com/device/K111520
Methodology: https://510kreport.com/methodology