# K211783: TriMed Threaded Intramedullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Aug 6, 2021 after 58 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: 13 generations back to K962616 (1996). 148 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K192745: DePuy Synthes Trauma Screws, Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. (2019) Summary page 4.
- K170021: SMV Scientific Cannulated Screws, Smv Scientific (2017) Summary page 4.
- K202589: APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System, Medartis AG (2020) Summary page 4.

## Most influential descendants
- K230749: TriMed Threaded Intramedullary Nail System (2023), 1 descendant of its own
- 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/K211783
Methodology: https://510kreport.com/methodology