# K231623: Distal Elbow Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, Inc.
- Decided: Aug 28, 2023 after 87 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 K082300 (2009). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171590: Distal Elbow Plating System, Skeletal Dynamics, LLC (2017) Summary page 4.
- K140892: Distal Elbow Plating System, Skeletal Dynamics, LLC (2014) Summary page 4.
- K082300: Anatomic Locking Plating System, DePuy Orthopaedics, Inc. (2009) Summary page 4.

## Indications for use
The Skeletal Dynamics Distal Elbow Plating System is indicated for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K231623
Methodology: https://510kreport.com/methodology