# K222390: Flex-Thread™ Ulna Intramedullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Flower Orthopedics Corporation Dba Conventus Flower
- Decided: Nov 21, 2022 after 105 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962823 (1996). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202858: Flex-ThreadTM Distal Fibula Intramedullary Nail System, Conventus Orthopaedics, LLC (2021) Summary page 4.
- K042135: Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension), Synthes (Usa) (2004) Summary page 4.

## Indications for use
The Flex-Thread ™ Ulna lntramedullary Nail System is intended for use in the fixation of fractures and osteotomies of the ulna.

Source page: https://510kreport.com/device/K222390
Methodology: https://510kreport.com/methodology