# K202552: Midas Rex Attachments and Dissecting Tools

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Powered Surgical Solutions (Mpss)
- Decided: Nov 2, 2020 after 60 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: 13 generations back to K862807 (1986). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183515: MR8 Drill System, Midas Rex MR8 ClearView Tools, Medtronic Powered Surgical Solutions (2019) Summary page 4.
- K183644: Stealth-Midas MR8 System, Medtronic Powered Surgical Solutions (2019) Summary page 4.

## Indications for use
The Midas Rexn attachments and dissecting tools for Mazor are indicated for the incision/cutting, drilling, burring, and removal of hard tissue and bone in open and minimally invasive spine procedures. Computer-assisted surgery and its associated applications are intended as an aid for locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition for 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/K202552
Methodology: https://510kreport.com/methodology