# K201962: Skeletal Dynamics Ulnar Shortening Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, Inc.
- Decided: Oct 13, 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: 7 generations back to K962616 (1996). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141232: Aptus Ulna Shortening 2.5, Medartis AG (2014) Summary page 4.
- K103332: Aptus Ulna Plates, Medartis AG (2011) Summary page 4.

## Indications for use
The Skeletal Dynamics Ulnar Shortening Plating System is indicated for fractures and osteotomies, in particular for the ulna.

Source page: https://510kreport.com/device/K201962
Methodology: https://510kreport.com/methodology