510(k) · Cleared
ClearedSurgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Apr 23, 1997 after a 121-day review. The FDA summary names its predicate without a number. 40 later devices descend from it.
- Decided
- Apr 23, 1997
- Review
- 121 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 4 citing it directly.
- This deviceK965139 Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator…Carl Zeiss, Inc. · 1997
- Descendant · cites it directly · 36 of its ownK981315 NavitrackOrthosoft, Inc. · 1998
- Descendant · 2 generations on · 35 of its ownK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- Descendant · 3 generations on · 34 of its ownK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- Descendant · 3 generations on · 33 of its ownK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- Descendant · 3 generations on · 32 of its ownK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K981315NavitrackOrthosoft, Inc. · 1998 · cites it directly36descendants
- K033413Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004 · 2 generations on35descendants
- K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005 · 3 generations on34descendants
- K063607Spineassist SystemMazor Surgical Technologies, Ltd. · 2007 · 3 generations on33descendants
- K073467Spineassist SystemMazor Surgical Technologies, Ltd. · 2008 · 3 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965139 | Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) System | Carl Zeiss, Inc. | 1997 | — |
| +1 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| +2 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| +3 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| +3 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| +3 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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.
Planning a device in HAW? 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? (2)
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 |
|---|---|---|---|
| * | — | MKM system (Multiple Coordinate Manipulator) Named without a submission number | |
| * | — | StealthStation Named without a submission number |
What descends from it? (40)
See all 404 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K981315 (Orthosoft, Inc., 1998) has gone furthest, with 36 descendants of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
These devices will be used in the same manner as all Surgical Microscope/ Image Guided Systems are used and as all Instrument Based Image Guided Systems are used. These devices are used to aid the surgeon in visualizing the surgical site and guiding the surgeon through the surgical course. The systems do not take the place of the surgeon they are only a tool used to assist the surgeon during the procedure. Decisions about what to do and how to perform a procedure still rest firmly with the surgeon. These systems incorporate the original intended uses of our MKM system and now the STN system can be used as a stand alone navigational tool.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965139 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965139: Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965139
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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