# K050973: Modification to: Voyager Linux

- Pathway: 510(k) (Special)
- Applicant: Mako Surgical Corp.
- Decided: May 17, 2005 after 29 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: 2 generations back to K000310 (2000). 2 ancestors in all.
97 later devices descend from it; 1 cites it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023975: Voyager Linux, Z-Kat, Inc. (2002) Summary page 1.

## Most influential descendants
- K052851: Voyager Linux with Tactile Guidance System (TGS) (2005), 96 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
- K112507: Restoris Partial Knee Application (Pka), Rio Standard System (2012), 46 descendants of its own
- K143752: Total Knee Application (TKA) (2015), 44 descendants of its own

## Indications for use
The Voyager Linux is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures. The Voyager Linux is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as: o Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous) o Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms o ENT Procedures o Orthopedic surgical procedures

Source page: https://510kreport.com/device/K050973
Methodology: https://510kreport.com/methodology