# K200367: Distal Humerus Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, Inc.
- Decided: May 14, 2020 after 90 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: 12 generations back to K962616 (1996). 81 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120717: Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates), Synthes USA (2012) Summary page 4.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 4.

## Most influential descendants
- K213895: Distal Humerus Plating System (2022), 0 descendants of its own

## Indications for use
The Skeletal Dynamics Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

Source page: https://510kreport.com/device/K200367
Methodology: https://510kreport.com/methodology