# K191597: Stealth Autoguide System, Midas Rex Legend Depth Stop System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Nov 1, 2019 after 137 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K862807 (1986). 87 ancestors in all.
4 later devices descend from it; 4 cite it directly.
1 of 92 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151359: ROSA Brain, Medtech S.A (2015) Summary page 6.
- K170312: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools, Medtronic Powered Surgical Solutions (2017) Summary page 6.
- K163182: Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories, Medtronic Powered Surgical Solutions (2017) Summary page 6.

## Most influential descendants
- K210989: Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System (2021), 2 descendants of its own
- K223864: Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial (2023), 1 descendant of its own
- K243698: Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT (2025), 0 descendants of its own
- 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 (2021), 0 descendants of its own

## Recalls of this device
- Nov 9, 2021 · Class II · Z-0417-2022: A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navig

## Indications for use
The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software. The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic biopsy, stereotactic EEG, laser tissue ablation, etc.). The Midas Rex™ Legend™ 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/K191597
Methodology: https://510kreport.com/methodology