# K964229: Regulus Navigator

- Pathway: 510(k) (Traditional)
- Applicant: Compass Intl., Inc.
- Decided: Aug 19, 1997 after 300 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 K911783 (1994). 6 ancestors in all.
66 later devices descend from it; 2 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935456: Regulus Measurement Unit, Compass Intl., Inc. (1995) Summary page 1.
- K871046: Compass Stereotactic Positioning System, Stereotactic Medical Systems, Inc. (1987) Summary page 1.
- K960714: Isg Viewing Wand, I.S.G. Technologies, Inc. (1996) Summary page 1.

## Most influential descendants
- K981315: Navitrack (1998), 36 descendants of its own
- 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

## Indications for use
Intraoperative Guidance Device to Localize a Surgical Field for Intra/Extracranial .. Usage

Source page: https://510kreport.com/device/K964229
Methodology: https://510kreport.com/methodology