# K103192: Navigation Marker, Reflective Marker Spheres

- Pathway: 510(k) (Traditional)
- Applicant: Ilumark GmbH
- Decided: Feb 7, 2011 after 101 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 K983831 (1999). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033621: Ndi Passive Spheres, Northern Digital, Inc. (2004) Summary page 1.
- K100038: Disposable Reflective Marker Spheres, Brainlab AG (2010) Summary page 1.

## Most influential descendants
- K111443: X12 Sterile Reflective Marker Sphere (2011), 0 descendants of its own

## Indications for use
ILUMARK Navigation Markers are intended to be used as image guided surgery system accessory to aid in auto-registration and localization of rigid patient anatomical structure in either open or percutaneous image guided surgery procedures. It is indicated for any medical condition in which the use of an image guided surgery system may be considered to be dppropriate. ILUMARK Navigation Markers can be used in following procedures: * Stereotactic brain surgery * Endoscopic Sinus Surgery * Pedicle Screw Placement * Reconstructive orthopedic surgery * Soft tissue treatment

Source page: https://510kreport.com/device/K103192
Methodology: https://510kreport.com/methodology