# K163565: MR8 Drill System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Powered Surgical Solutions
- Decided: Mar 28, 2017 after 99 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: 7 generations back to K862807 (1986). 29 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have 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 4.
- K090112: Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700, Medtronic Powered Surgical Solutions (2009) Summary page 5.
- K020069: Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System, Medtronic Midas Rex (2002) Summary page 5.

## Most influential descendants
- K183515: MR8 Drill System, Midas Rex MR8 ClearView Tools (2019), 4 descendants of its own
- K183644: Stealth-Midas MR8 System (2019), 3 descendants of its own
- K233638: VERZA™ High Speed Drills (2024), 1 descendant of its own
- K240568: DuraPro™ Oscillating System (2024), 0 descendants of its own
- K233958: hekaDrill (2024), 0 descendants of its own

## Indications for use
The Medtronic MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Cranial and Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

Source page: https://510kreport.com/device/K163565
Methodology: https://510kreport.com/methodology