510(k) · Cleared
Recalled · Class II · 2015Brightmatter Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synaptive Medical, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Apr 2, 2015 as substantially equivalent to K062640 (Stryker Instruments, 2006) after a 251-day review. Its family tree reaches back 2 generations to 2000. 1 of the 17 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it. It has been recalled once.
- Decided
- Apr 2, 2015
- Review
- 251 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993239 (2000). 4 ancestors in all. 12 later devices descend from it, 4 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 1 generation backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- This deviceK142024 Brightmatter Navigation SystemSynaptive Medical, Inc. · 2015
- Descendant · cites it directly · 6 of its ownK181041 7D Surgical System Cranial Application7D Surgical, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK192945 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement…7D Surgical, Inc. · 2019
- Descendant · 3 generations on · 3 of its ownK230661 Zeta Cranial Navigation SystemZeta Surgical · 2023
- Descendant · 4 generations on · 2 of its ownK233903 Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK153281 BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc. · 2016 · Recalled (Class I)
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K153281 BrightMatter Guide with Surface Trace Registrationcites it directly · 2016
Most influential descendants
Showing 5 of 12 · See all- K1810417D Surgical System Cranial Application7D Surgical, Inc. · 2018 · cites it directly6descendants
- K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical, Inc. · 2019 · 2 generations on5descendants
- K230661Zeta Cranial Navigation SystemZeta Surgical · 2023 · 3 generations on3descendants
- K233903Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2024 · 4 generations on2descendants
- K153281BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc. · 2016 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −1 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| 0 (this device) | K142024 | Brightmatter Navigation System | Synaptive Medical, Inc. | 2015 | — |
| +1 | K181041 | 7D Surgical System Cranial Application | 7D Surgical, Inc. | 2018 | — |
| +2 | K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 7D Surgical, Inc. | 2019 | — |
| +3 | K230661 | Zeta Cranial Navigation System | Zeta Surgical | 2023 | — |
| +4 | K233903 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024 | — |
| +1 | K153281 | BrightMatter Guide with Surface Trace Registration | Synaptive Medical, Inc. | 2016 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 3 | 1 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000Summary page 4…eotaxic instrument (21 CFR 882.4560) Regulatory Class: II Product Code: HAW III. PREDICATE DEVICE Stryker Navigation System – Cranial Module by Stryker Corporation, K062640 Date cleared: December 14, 2006 IV. DEVICE DESCRIPTION The subject device, BrightMatter Navigation system, is a planning an… | 2006 |
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 4, 2015 | Class II | Z-0480-2016 | Component design/selection | 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 60601-1-2:2007 (Ed3.0) standard specification. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153281BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc. · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K181041 (7D Surgical, Inc., 2018) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K062640.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142024: Brightmatter Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142024
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026