# K234040: TriMed Threaded Intramedullary Nail System

- Pathway: 510(k) (Special)
- Applicant: TriMed, Inc.
- Decided: Jan 18, 2024 after 28 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K962616 (1996). 150 ancestors in all.
No later device cites it as a predicate yet.
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.
- K230749: TriMed Threaded Intramedullary Nail System, TriMed, Inc. (2023) Summary page 4.

## Recalls of this device
- Mar 19, 2024 · Class II · Z-1791-2024: Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
- Mar 19, 2024 · Class II · Z-1792-2024: Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.

## Indications for use
The TriMed Threaded IM Nail System is indicated 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/K234040
Methodology: https://510kreport.com/methodology