# K171467: BioZorb Marker GOLD / LP Marker GOLD

- Pathway: 510(k) (Traditional)
- Applicant: Focal Therapeutics
- Decided: Nov 9, 2017 after 175 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K935844 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
2 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071614: Fiducial Markers, Civco (2007) Summary page 4.
- K143484: BioZorb Marker, Focal Therapeutics (2015) Summary page 4.
- K152070: BioZorb LP Marker, Focal Therapeutics (2015) Summary page 4.
- K132708: Biomarc Fiducial Marker, Carbon Medical Technologies, Inc. (2013) Summary page 4.
- K110772: Biomarc Fiducial Marker, Carbon Medical Technologies, Inc. (2011) Summary page 4.

## Indications for use
The Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.

Source page: https://510kreport.com/device/K171467
Methodology: https://510kreport.com/methodology