# K160523: BrightMatter Guide with BrightMatter Pointer

- Pathway: 510(k) (Traditional)
- Applicant: Synaptive Medical, Inc.
- Decided: Jun 24, 2016 after 120 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: 4 generations back to K993239 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
1 of 12 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 5.
- K153281: BrightMatter Guide with Surface Trace Registration, Synaptive Medical, Inc. (2016). Cleared while this submission was under review Summary page 5.
- K142344: DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System, Izi Medical Products, LLC (2015) Summary page 5.
- K080450: Stryker Power Tool Navigator Attachment, Stryker Corp. (2008) Summary page 5.

## Indications for use
BrightMatter Guide 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 BrightMatter Pointer is intended to be used for anatomy palpation and as a pointing tool to enable spatial localization and identification by BrightMatter Guide navigational systems. The system should be operated only by trained personnel such as surgeons and other clinic staff.

Source page: https://510kreport.com/device/K160523
Methodology: https://510kreport.com/methodology