# K123270: Powerease System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jan 11, 2013 after 84 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- 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). 59 ancestors in all.
398 later devices descend from it; 4 cite it directly.
1 of 458 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111520: Ipc Powerease System, Medtronic Xomed, Inc. (2011) Summary page 2.

## Most influential descendants
- K140454: Navigated CD Horizon Solera Screwdriver/Taps (2014), 396 descendants of its own
- K150231: Navigated Disc Prep Instruments and CAPSTONE Trials (2015), 242 descendants of its own
- K143375: CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments (2015), 207 descendants of its own
- K143628: Navigated Vertex Select Instruments (2015), 206 descendants of its own
- K153203: Navigation Instruments (2016), 112 descendants of its own

## Indications for use
IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomtaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC® POWEREASETM 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 placement or cutting of screws, posts and rods.

Source page: https://510kreport.com/device/K123270
Methodology: https://510kreport.com/methodology