# K163014: AOS Small Bone Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Orthopaedic Solutions, Inc. (Aos)
- Decided: Jan 24, 2017 after 88 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: 5 generations back to K960642 (1996). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 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.
- K031438: Acumed Small Bone Locking Rod System II, Acumed, LLC (2003) Summary page 4.
- K143276: Acumed Small Bone IM Nail System, Acumed, LLC (2015) Summary page 4.
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap, Smith & Nephew, Inc. (1998) Summary page 4.

## Most influential descendants
- K234128: Phantom Fibula Nail System (2024), 0 descendants of its own

## Indications for use
The AOS Small Bone 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/K163014
Methodology: https://510kreport.com/methodology