# K180352: 7D Surgical System

- Pathway: 510(k) (Special)
- Applicant: 7D Surgical, Inc.
- Decided: May 2, 2018 after 83 days
- Product code: OLO (Orthopedic 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 K050438 (2005). 3 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K192140: 7D Surgical System (2019), 3 descendants of its own
- K222753: SeaSpine 7D Navigation Instruments (2022), 1 descendant of its own
- K191012: Navigated Pedicle Access Kit (2019), 1 descendant of its own
- K243659: FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (2025), 0 descendants of its own
- K232800: Navigation Tracking Instruments (2024), 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 posterior approach spine surgery where reference to a rigid anatomical structure can be identified.

Source page: https://510kreport.com/device/K180352
Methodology: https://510kreport.com/methodology