# K984298: Z Kat Flurotactic Guidance System Mki

- Pathway: 510(k) (Traditional)
- Applicant: Z-Kat, Inc.
- Decided: Jun 23, 1999 after 203 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: 4 generations back to K905070 (1991). 9 ancestors in all.
152 later devices descend from it; 1 cites it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 1.
- K961844: Operating Arm System (Oas) [with CT and MR Images], Radionics Software Applications, Inc. (1996) Summary page 1.
- K970604: Viewpoint - 3.0 Software, Philips Medical Systems (Cleveland), Inc. (1997) Summary page 1.
- K861692: Fischer PPS/Mammotest Mammography System, Fischer Imaging Corp. (1986) Summary page 1.

## Most influential descendants
- K013025: Modification to Flourolab Plus (2001), 151 descendants of its own
- 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

## Indications for use
The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a linear trajectory insertion or placement is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle. The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic images, which will then be displayed on two computer screens. The surgeon will manipulate a virtual guidewire on the screens, until the desired angle and placement is achieved. The system will then output 3D coordinates to the robot arm which will move the drill guide to a precise position.

Source page: https://510kreport.com/device/K984298
Methodology: https://510kreport.com/methodology