# K172943: Flex-Thread Fibula Pin System

- Pathway: 510(k) (Traditional)
- Applicant: Intrafuse, LLC
- Decided: Oct 30, 2017 after 34 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: 8 generations back to K962823 (1996). 57 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K102845: Mahe Fixation Plate and Screw System, Mahe Medical GmbH (2011) Summary page 4.
- K142945: Sonoma Fibula Repair System, Sonoma Orthopedic Products, Inc. (2015) Summary page 4.
- K160069: Sonoma Fibula Repair System, Sonoma Orthopedics Products, Inc. (2016) Summary page 4.
- K143276: Acumed Small Bone IM Nail System, Acumed, LLC (2015) Summary page 4.
- K071944: Acumed Small Bone Locking System II, Acumed, LLC (2007). Our reading of the summary gave K071994, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words.
- K031438: Acumed Small Bone Locking Rod System II, Acumed, LLC (2003) Summary page 4.

## Most influential descendants
- K202858: Flex-ThreadTM Distal Fibula Intramedullary Nail System (2021), 3 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K172943
Methodology: https://510kreport.com/methodology