# K143204: AOS Clavicle Intramedullary Device

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Orthopaedic Solutions, Inc.
- Decided: Jun 3, 2015 after 208 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: 3 generations back to K903258 (1990). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103001: Rockwood Clavicle Pins, DePuy Orthopaedics, Inc. (2011) Summary page 4.

## Most influential descendants
- K163488: Flex-Thread Clavicle Pin System (2017), 1 descendant of its own
- K201830: ANSER Clavicle Pin (2020), 0 descendants of its own

## Indications for use
The AOS Clavicle Intramedullary Device is intended to be used to repair an acute fracture, mal-union, or non-union of the Clavicle.

Source page: https://510kreport.com/device/K143204
Methodology: https://510kreport.com/methodology