# K110700: Ascension Atlas Humeral Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Dec 6, 2011 after 267 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: 1 generation back to K011815 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001)

## Most influential descendants
- K121826: Integra Proximal Humeral Plate System (2013), 0 descendants of its own

## Indications for use
The Ascension® ATLAS® Humeral Fracture Plate system is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications Include: Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures involving osteopenic bone Pseudoarthroses in the proximal humerus Osteotomies in the proximal humerus

Source page: https://510kreport.com/device/K110700
Methodology: https://510kreport.com/methodology