# K213454: Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm

- Pathway: 510(k) (Special)
- Applicant: Medtronic Powered Surgical Solutions
- Decided: Nov 23, 2021 after 28 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: 11 generations back to K862807 (1986). 88 ancestors in all.
No later device cites it as a predicate yet.
1 of 89 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191597: Stealth Autoguide System, Midas Rex Legend Depth Stop System, Medtronic Navigation, Inc. (2019) Summary page 4.

## Indications for use
The Midas Rex MR8 Depth Stop attachment and tools are indicated for the incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

Source page: https://510kreport.com/device/K213454
Methodology: https://510kreport.com/methodology