BRIGHTMATTER NAVIGATION SYSTEM— 510(k) K142024

Clearance details

Applicant

Synaptive Medical, Inc.

Product code

Code HAW

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2014-07-25

Decision date

2015-04-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Toronto, CA

• K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)2026-09-10
• K261932 — Leksell® Vantage Stereotactic System2026-08-05
• K253663 — Zeta Navigation System2026-05-01
• K253379 — Stealth AXiS Cranial clinical application2026-03-26
• K231897 — NeuroAlign software2025-10-21

• K231986 — Modus IR2024-03-25
• K232981 — Synq Software Version 1.32023-10-11
• K200327 — Evry2020-04-29
• K183325 — Modus Nav2019-07-14
• K180394 — BrightMatter Plan 1.6.02018-03-09

Death

52

Injury

1,083

Malfunction

17,300

Total

18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0480-2016 — Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. 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. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.Class II·Terminated·Synaptive Medical, Inc.·20151204

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142024.