# K092720: Wrist Arthrodesis Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, LLC
- Decided: Jun 29, 2010 after 298 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042355 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042355: Synthes (Usa) LCP Wrist Fusion Plates, Synthes (Usa) (2004) Summary page 1.

## Indications for use
The Wrist Arthrodesis Nail System is intended for wrist arthrodesis. Specific indications include post-traumatic arthritis of the joints of the wrist, rheumatoid wrist deformities requiring restoration, complex carpal instability, post-septic arthritis of the wrist, severe unremitting wrist pain related to motion, brachial plexus nerve palsies, tumor resection, and spastic deformities.

Source page: https://510kreport.com/device/K092720
Methodology: https://510kreport.com/methodology