# K230749: TriMed Threaded Intramedullary Nail System

- Pathway: 510(k) (Special)
- Applicant: TriMed, Inc.
- Decided: Apr 17, 2023 after 31 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962616 (1996). 149 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211783: TriMed Threaded Intramedullary Nail System, TriMed, Inc. (2021) Summary page 4.

## Most influential descendants
- K234040: TriMed Threaded Intramedullary Nail System (2024), 0 descendants of its own

## Indications for use
The TriMed Threaded IM Nail System is intended for the treatment of select fractures and corrective osteotomies of short tubular bones. Specific indications for TriMed Small Threaded IM Nails include: 1. Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies 2. Metacarpal fractures, non-unions, malunions and corrective osteotomies

Source page: https://510kreport.com/device/K230749
Methodology: https://510kreport.com/methodology