# K183644: Stealth-Midas MR8 System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Powered Surgical Solutions
- Decided: May 22, 2019 after 147 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K862807 (1986). 74 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160713: Stealth-Midas System, Medtronic Powered Surgical Solutions (2016) Summary page 4.
- K183515: MR8 Drill System, Midas Rex MR8 ClearView Tools, Medtronic Powered Surgical Solutions (2019). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K233638: VERZA™ High Speed Drills (2024), 1 descendant of its own
- K240568: DuraPro™ Oscillating System (2024), 0 descendants of its own
- K202552: Midas Rex Attachments and Dissecting Tools (2020), 0 descendants of its own

## Indications for use
The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

Source page: https://510kreport.com/device/K183644
Methodology: https://510kreport.com/methodology