# K100038: Disposable Reflective Marker Spheres

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jul 14, 2010 after 188 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K983831 (1999). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082060: Cranial Image Guided Surgery System, Brainlab AG (2009) Summary page 1.

## Most influential descendants
- K103192: Navigation Marker, Reflective Marker Spheres (2011), 1 descendant of its own
- K111443: X12 Sterile Reflective Marker Sphere (2011), 0 descendants of its own

## Recalls of this device
- Aug 18, 2015 · Class II · Z-2795-2015: Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together.
- Jun 10, 2015 · Class II · Z-2084-2015: Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
- May 20, 2015 · Class II · Z-2093-2015: Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.

## Indications for use
Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling infrared tracking systems to detect the position of the patient and instruments in the surgical field.

Source page: https://510kreport.com/device/K100038
Methodology: https://510kreport.com/methodology