# K190166: TriMed Nitinol Staple System

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Jul 1, 2019 after 151 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K915818 (1992). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112794: Eos Small Bone Fixation System, TriMed, Inc. (2012) Summary page 5.

## Indications for use
The TriMed Nitinol Staple System is intended for use in fractures, osteotomy, and arthrodesis of the following areas of the body: small bones in the hand and foot.

Source page: https://510kreport.com/device/K190166
Methodology: https://510kreport.com/methodology