# K160069: Sonoma Fibula Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Orthopedics Products, Inc.
- Decided: Mar 10, 2016 after 57 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: 4 generations back to K913949 (1992). 6 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142945: Sonoma Fibula Repair System, Sonoma Orthopedic Products, Inc. (2015) Summary page 6.
- K071944: Acumed Small Bone Locking System II, Acumed, LLC (2007) Summary page 6.
- K031438: Acumed Small Bone Locking Rod System II, Acumed, LLC (2003) Summary page 6.

## Most influential descendants
- K172943: Flex-Thread Fibula Pin System (2017), 4 descendants of its own
- K202858: Flex-ThreadTM Distal Fibula Intramedullary Nail System (2021), 3 descendants of its own
- K173656: Arthrex FibuLock Nail (2018), 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

## Indications for use
The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures and osteotomies.

Source page: https://510kreport.com/device/K160069
Methodology: https://510kreport.com/methodology