# K965139: Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) System

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss, Inc.
- Decided: Apr 23, 1997 after 121 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
No predicates in its family tree.
40 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MKM system (Multiple Coordinate Manipulator): named in the summary without a submission number
- (no number) StealthStation: named in the summary without a submission number

## Most influential descendants
- K981315: Navitrack (1998), 36 descendants of its own
- K033413: Spineassist Device (2004), 35 descendants of its own
- K051676: Spineassist Device with Additional Accessories (2005), 34 descendants of its own
- K063607: Spineassist System (2007), 33 descendants of its own
- K073467: Spineassist System (2008), 32 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K965139
Methodology: https://510kreport.com/methodology