# K171257: ClearPoint System

- Pathway: 510(k) (Traditional)
- Applicant: Mri Interventions, Inc.
- Decided: Oct 20, 2017 after 175 days
- Product code: ORR (Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri)
- 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: 8 generations back to K031815 (2003). 12 ancestors in all.
8 later devices descend from it; 1 cites it directly.
4 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160434: ClearPoint System, Mri Interventions, Inc. (2016) Summary page 4.

## Most influential descendants
- K181195: ClearPoint System (2018), 7 descendants of its own
- K200079: ClearPoint System and Accessories (2020), 3 descendants of its own
- K222519: ClearPoint System (2022), 2 descendants of its own
- K202575: ClearPoint Array System (2021), 2 descendants of its own
- K233243: ClearPoint System (Software Version 2.2) (2023), 1 descendant of its own

## Indications for use
The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices. The user should consult the "Navigational Accuracy" section of the User’s Guide to assess if the accuracy of the system is suitable for their needs.

Source page: https://510kreport.com/device/K171257
Methodology: https://510kreport.com/methodology