# K153281: BrightMatter Guide with Surface Trace Registration

- Pathway: 510(k) (Traditional)
- Applicant: Synaptive Medical, Inc.
- Decided: Mar 30, 2016 after 139 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K993239 (2000). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142024: Brightmatter Navigation System, Synaptive Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K183325: Modus Nav (2019), 0 descendants of its own
- K160523: BrightMatter Guide with BrightMatter Pointer (2016), 0 descendants of its own

## Recalls of this device
- Oct 9, 2018 · Class I · Z-0470-2019: This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port 

## Indications for use
BrightMatter Guide with SurfaceTrace Registration 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 intraoperative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the “Accuracy Characterization” section of the User Manual to assess if the accuracy of the system is suitable for their needs. The system should be operated only by trained personnel such as surgeons and other clinic staff.

Source page: https://510kreport.com/device/K153281
Methodology: https://510kreport.com/methodology