# K143484: BioZorb Marker

- Pathway: 510(k) (Traditional)
- Applicant: Focal Therapeutics
- Decided: Jun 29, 2015 after 203 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001807 (2001). 12 ancestors in all.
7 later devices descend from it; 5 cite it directly.
2 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102506: Mixed Media Marker, Cortex Manufacturing, Inc. (2011) Summary page 4.
- K071614: Fiducial Markers, Civco (2007) Summary page 4.
- K113202: Tissue Marker, Focal Therapeutics (2012) Summary page 4.

## Most influential descendants
- K152070: BioZorb LP Marker (2015), 5 descendants of its own
- K180640: SmartClip Soft Tissue Marker (2018), 1 descendant of its own
- K233639: SmartClip Secure Soft Tissue Marker (2024), 0 descendants of its own
- K192371: BioZorb SP Marker (2019), 0 descendants of its own
- K180027: ACCUSYTE 3D Fiducial Marker (2018), 0 descendants of its own

## Recalls of this device
- Oct 10, 2024 · Class I · Z-0328-2025: Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

## Indications for use
The BioZorb Marker is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

Source page: https://510kreport.com/device/K143484
Methodology: https://510kreport.com/methodology