# K071944: Acumed Small Bone Locking System II

- Pathway: 510(k) (Special)
- Applicant: Acumed, LLC
- Decided: Aug 9, 2007 after 27 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: 2 generations back to K913949 (1992). 4 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031438: Acumed Small Bone Locking Rod System II, Acumed, LLC (2003) Summary page 1.

## Most influential descendants
- K142945: Sonoma Fibula Repair System (2015), 10 descendants of its own
- K160069: Sonoma Fibula Repair System (2016), 9 descendants of its own
- 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

## Indications for use
The Acumed Small Bone Locking Rod System II includes rods and screws, with accessories, for indicated use for fractures and osteotomies of the radius, ulna, and fibula.

Source page: https://510kreport.com/device/K071944
Methodology: https://510kreport.com/methodology