# K170905: Star Tissue Marker

- Pathway: 510(k) (Special)
- Applicant: Scion Medical Technologies, LLC
- Decided: Apr 27, 2017 after 30 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001807 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140835: General and Plastic Surgery, Scion Medical Technologies, LLC (2014) Summary page 4.

## Indications for use
Star Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures

Source page: https://510kreport.com/device/K170905
Methodology: https://510kreport.com/methodology