# K240429: Trilogy Tissue Marker

- Pathway: 510(k) (Traditional)
- Applicant: Inrad, Inc.
- Decided: Nov 7, 2024 after 268 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: 3 generations back to K970817 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183503: EasyMark Tissue Marker, Inrad, Inc. (2019) Summary page 5.

## Indications for use
The Trilogy Tissue Marker is intended for use to attach to breast tissue at the surgical site during an open surgical breast biopsy or percutaneous breast biopsy to radiographically mark the location of the biopsy procedure, and be permanently visible under MRI, x-ray and ultrasound.

Source page: https://510kreport.com/device/K240429
Methodology: https://510kreport.com/methodology