# K181035: AOS Small Fragment Plating System Lite

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Orthopaedic Solutions, Inc. (Aos)
- Decided: Aug 24, 2018 after 128 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: 3 generations back to K000684 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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) Summary page 4.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.
- K161913: AOS Small Fragment Plating System, Advanced Orthopaedic Solutions, Inc. (Aos) (2016) Summary page 4.

## Most influential descendants
- K182466: AOS Calcaneal Plating System (2018), 0 descendants of its own

## Indications for use
The AOS Small Fragment Plating System Lite is intended to be used for fixations of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and/or fibula, including osteopenic bone.

Source page: https://510kreport.com/device/K181035
Methodology: https://510kreport.com/methodology