# K160713: Stealth-Midas System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Powered Surgical Solutions
- Decided: May 26, 2016 after 72 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: 11 generations back to K862807 (1986). 66 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 76 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 5.
- K090112: Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700, Medtronic Powered Surgical Solutions (2009) Summary page 5.
- K143628: Navigated Vertex Select Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.

## Most influential descendants
- K220241: “POINT” Kinguide Robotic-Assisted Surgical System (2022), 4 descendants of its own
- K230087: “POINT” Kinguide Agile Hybrid Navigation System (2023), 3 descendants of its own
- K183644: Stealth-Midas MR8 System (2019), 3 descendants of its own
- K241130: “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) (2024), 2 descendants of its own
- K233638: VERZA™ High Speed Drills (2024), 1 descendant of its own

## Indications for use
The Stealth-Midas System is indicated for the drilling, burring and removal of hard tissue and bone in spinal 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/K160713
Methodology: https://510kreport.com/methodology