# K143241: MDT Navigable Brain Biopsy Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Izi Medical Products, LLC
- Decided: Apr 13, 2015 after 152 days
- Product code: HAW (Neurological 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: 1 generation back to K971247 (1997). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971247: SNT Disposable Biopsy Needle, Surgical Navigation Technologies, Inc. (1997) Summary page 4.

## Most influential descendants
- K212194: Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System (2023), 1 descendant of its own
- K233542: Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System (2024), 0 descendants of its own

## Indications for use
The MDT Navigable Brain Biopsy Cannula is for use in stereotaxic biopsy of cranial tissue. The MDT Navigable Brain Biopsy Cannula is a pre-sterilized, single-use, sidecutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula. The device is compatible with Medtronic’s StealthStation® Image Guided Surgery System.

Source page: https://510kreport.com/device/K143241
Methodology: https://510kreport.com/methodology