# K182466: AOS Calcaneal Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Orthopaedic Solutions
- Decided: Oct 30, 2018 after 50 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K000684 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001)
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 4.
- K181035: AOS Small Fragment Plating System Lite, Advanced Orthopaedic Solutions, Inc. (Aos) (2018) Summary page 4.

## Indications for use
The AOS Calcaneal Plating System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K182466
Methodology: https://510kreport.com/methodology