510(k) · Cleared
ClearedBrightMatter Guide with BrightMatter Pointer
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 Jun 24, 2016 as substantially equivalent to K142024 (Synaptive Medical, Inc., 2015) and 3 other predicates after a 120-day review. Its family tree reaches back 4 generations to 2000. 1 of the 12 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 24, 2016
- Review
- 120 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K993239 (2000). 11 ancestors in all. No later device cites it as a predicate yet. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 3 generations backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- 2 generations backK142024 Brightmatter Navigation SystemSynaptive Medical, Inc. · 2015 · Recalled
- 1 generation backK153281 BrightMatter Guide with Surface Trace RegistrationSynaptive Medical, Inc. · 2016 · Recalled (Class I)
- This deviceK160523 BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. · 2016
Class I recalls in this family
- K153281 BrightMatter Guide with Surface Trace Registrationdirect predicate · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −3 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| −2 | K142024 | Brightmatter Navigation System | Synaptive Medical, Inc. | 2015 | 1 |
| −1 | K153281 | BrightMatter Guide with Surface Trace Registration | Synaptive Medical, Inc. | 2016 | Class I |
| 0 (this device) | K160523 | BrightMatter Guide with BrightMatter Pointer | Synaptive Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 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? (4)
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 |
|---|---|---|---|
| * | K142024 | Brightmatter Navigation SystemSummary page 5…ry Number Predicate BrightMatter Navigation System v1.0 / Synaptive, Inc. K142024 BrightMatter Guide with Surface… | 2015 |
| * | K153281 | BrightMatter Guide with Surface Trace Registration Cleared while this submission was under review Summary page 5…, Inc. K142024 BrightMatter Guide with Surface Trace Registration / K153281 Synaptive, Inc. Disposable Passive Accessory for Medtronic StealthStation K142344… | 2016 |
| * | K142344 | DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation SystemSummary page 5…ghtMatter Guide with Surface Trace Registration / K153281 Synaptive, Inc. Disposable Passive Accessory for Medtronic StealthStation K142344 System / IZI Medical Products LLC Stryker Power Tool Navigator / Stryker Instruments K080450… | 2015 |
| * | K080450 | Stryker Power Tool Navigator AttachmentSummary page 5…Accessory for Medtronic StealthStation K142344 System / IZI Medical Products LLC Stryker Power Tool Navigator / Stryker Instruments K080450 2 510(k) Sum… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 7 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K142024.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 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…
Read the full statement (129 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160523: BrightMatter Guide with BrightMatter Pointer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160523
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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