# K142024: Brightmatter Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Synaptive Medical, Inc.
- Decided: Apr 2, 2015 after 251 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: 2 generations back to K993239 (2000). 4 ancestors in all.
12 later devices descend from it; 4 cite it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062640: Stryker Navigation System - Cranial Module, Model 6000-650-000, Stryker Instruments (2006) Summary page 4.

## Most influential descendants
- K181041: 7D Surgical System Cranial Application (2018), 6 descendants of its own
- K192945: 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application (2019), 5 descendants of its own
- K230661: Zeta Cranial Navigation System (2023), 3 descendants of its own
- K233903: Zeta Cranial Navigation System (ZNS131-US) (2024), 2 descendants of its own
- K153281: BrightMatter Guide with Surface Trace Registration (2016), 2 descendants of its own

## Recalls of this device
- Dec 4, 2015 · Class II · Z-0480-2016: Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:

## Indications for use
BrightMatter Navigation System is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified. The system should be operated only by trained personnel such as surgeons and other clinic staff.

Source page: https://510kreport.com/device/K142024
Methodology: https://510kreport.com/methodology