# K111443: X12 Sterile Reflective Marker Sphere

- Pathway: 510(k) (Traditional)
- Applicant: Pinsco Inc. Dba B & L Engineering
- Decided: Sep 29, 2011 after 128 days
- Product code: OLO (Orthopedic 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: 6 generations back to K983831 (1999). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100038: Disposable Reflective Marker Spheres, Brainlab AG (2010) Summary page 1.
- K033621: Ndi Passive Spheres, Northern Digital, Inc. (2004) Summary page 1.
- K103192: Navigation Marker, Reflective Marker Spheres, Ilumark GmbH (2011) Summary page 1.

## Indications for use
Used as an accessory to aid in the auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgical procedures.

Source page: https://510kreport.com/device/K111443
Methodology: https://510kreport.com/methodology