# K202858: Flex-ThreadTM Distal Fibula Intramedullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Conventus Orthopaedics, LLC
- Decided: Jan 22, 2021 after 116 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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: 9 generations back to K962823 (1996). 58 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172943: Flex-Thread Fibula Pin System, Intrafuse, LLC (2017) Summary page 4.

## Most influential descendants
- K212030: Flex-Thread™ Distal Fibula lntramedullary Nail System (2021), 1 descendant of its own
- K252961: Fusion FibFix Nail (2026), 0 descendants of its own
- K222390: Flex-Thread™ Ulna Intramedullary Nail System (2022), 0 descendants of its own

## Recalls of this device
- Aug 29, 2023 · Class II · Z-0074-2024: Device is breaking while in use, potential for patients to require a revision surgery.
- Nov 2, 2021 · Class II · Z-0448-2022: Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a s

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

Source page: https://510kreport.com/device/K202858
Methodology: https://510kreport.com/methodology