# K121826: Integra Proximal Humeral Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Feb 13, 2013 after 237 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: 2 generations back to K011815 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
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) Summary page 1.
- K110700: Ascension Atlas Humeral Plating System, Ascension Orthopedics, Inc. (2011). Our reading of the summary gave K010700, FDA’s number for Randox Myoglobin (Randox Laboratories, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ATLAS Humeral Plate System”. Summary page 2.

## Indications for use
The Integra Proximal 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/K121826
Methodology: https://510kreport.com/methodology