# K143276: Acumed Small Bone IM Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Feb 5, 2015 after 83 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 K960642 (1996). 11 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971783: Synthes Elastic Intramedullary Nail (Ein) System, Synthes (Usa) (1997) Summary page 4.
- K082148: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension, Synthes (Usa) (2008) Summary page 4.
- K031438: Acumed Small Bone Locking Rod System II, Acumed, LLC (2003) Summary page 4.

## 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
- K212030: Flex-Thread™ Distal Fibula lntramedullary Nail System (2021), 1 descendant of its own
- K163014: AOS Small Bone Nailing System (2017), 1 descendant of its own
- K252961: Fusion FibFix Nail (2026), 0 descendants of its own

## Indications for use
The Acumed Small Bone IM Nail System is intended for fixation of fractures and osteotomies of the fibula, radius, and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.

Source page: https://510kreport.com/device/K143276
Methodology: https://510kreport.com/methodology