# K013025: Modification to Flourolab Plus

- Pathway: 510(k) (Special)
- Applicant: Z-Kat, Inc.
- Decided: Oct 3, 2001 after 23 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: 5 generations back to K905070 (1991). 13 ancestors in all.
151 later devices descend from it; 3 cite it directly.
0 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984298: Z Kat Flurotactic Guidance System Mki, Z-Kat, Inc. (1999) Summary page 1.
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 1.
- K990214: Fluoronav Module for the Stealthstation System, Surgical Navigation Technologies, Inc. (1999) Summary page 1.
- K000310: Voyager 6.0 Software Option, Philips Medical Systems (Cleveland), Inc. (2000) Summary page 1.
- K962939: Vectorvision, Brainlab, Inc. (1997) Summary page 1.

## Most influential descendants
- K031454: Acumen Surgical Navigation System (2004), 146 descendants of its own
- K031337: Acumen Surgical Navigation System (2003), 81 descendants of its own
- K072806: Mako Surgical Tactile Guidance System (TGS) (2008), 78 descendants of its own
- K081867: Mako Surgical Tactile Guidance System Version 2.0 (2008), 76 descendants of its own
- K111863: Signature Planner,Signature Guides (2012), 71 descendants of its own

## Indications for use
FluoroLab Plus will be used to assist in the alignment of surgical instruments by providing the surgeon with intraoperative navigational guidance based on pre-acquired fluoroscopic images. This system will use coordinated-fluoroscopy to allow intra-operative planning of the alignment of surgical tools such as a screw, nail, or needle.

Source page: https://510kreport.com/device/K013025
Methodology: https://510kreport.com/methodology