# K212030: Flex-Thread™ Distal Fibula lntramedullary Nail System

- Pathway: 510(k) (Special)
- Applicant: Flower Orthopedics Corporation Dba Conventus Flower
- Decided: Jul 23, 2021 after 24 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.
1 later device descends from it; 1 cites it directly.
0 of 61 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.

## Most influential descendants
- K252961: Fusion FibFix Nail (2026), 0 descendants of its own

## Indications for use
The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.

Source page: https://510kreport.com/device/K212030
Methodology: https://510kreport.com/methodology