# K213895: Distal Humerus Plating System

- Pathway: 510(k) (Special)
- Applicant: Skeletal Dynamics, Inc.
- Decided: Jan 13, 2022 after 30 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: 13 generations back to K962616 (1996). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200367: Distal Humerus Plating System, Skeletal Dynamics, Inc. (2020) Summary page 4.

## Indications for use
The Skeletal Dynamics Inc’s 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/K213895
Methodology: https://510kreport.com/methodology