# K181041: 7D Surgical System Cranial Application

- Pathway: 510(k) (Traditional)
- Applicant: 7D Surgical, Inc.
- Decided: Aug 8, 2018 after 111 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
Longest line of descent: 3 generations back to K993239 (2000). 7 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162375: Envision 3D: Image Guidance System, 7D Surgical, Inc. (2016) Summary page 4.
- K133444: Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System, Medtronic Navigation, Inc. (2014) Summary page 4.
- K142024: Brightmatter Navigation System, Synaptive Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K192945: 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application (2019), 5 descendants of its own
- K230661: Zeta Cranial Navigation System (2023), 3 descendants of its own
- K233903: Zeta Cranial Navigation System (ZNS131-US) (2024), 2 descendants of its own
- K242351: Zeta Cranial Navigation System (ZNS131-US) (2024), 1 descendant of its own
- K253663: Zeta Navigation System (2026), 0 descendants of its own

## Indications for use
The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for cranial surgery where reference to a rigid anatomical structure can be identified.

Source page: https://510kreport.com/device/K181041
Methodology: https://510kreport.com/methodology