# K981315: Navitrack

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft, Inc.
- Decided: Jul 9, 1998 after 90 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 K911783 (1994). 8 ancestors in all.
36 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964229: Regulus Navigator, Compass Intl., Inc. (1997) Summary page 1.
- K965139: Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) System, Carl Zeiss, Inc. (1997) Summary page 1.

## Most influential descendants
- K033413: Spineassist Device (2004), 35 descendants of its own
- K051676: Spineassist Device with Additional Accessories (2005), 34 descendants of its own
- K063607: Spineassist System (2007), 33 descendants of its own
- K073467: Spineassist System (2008), 32 descendants of its own
- K102130: Tenzing System (2010), 31 descendants of its own

## Indications for use
The Navitrack™ System is a stereotaxic instrument indicated for use in precisely positioning instruments or implants during orthopedic surgery, such as operation perform within spinal structures.

Source page: https://510kreport.com/device/K981315
Methodology: https://510kreport.com/methodology