# K192473: Exsomed Wrist Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Exsomed Corporation
- Decided: Dec 3, 2019 after 84 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: 1 generation back to K030310 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 4.
- K081546: Small Bone Locking Plating System, DePuy Orthopaedics, Inc. (2008) Summary page 4.

## Indications for use
The Exsomed Wrist Plating System is intended for the repair of fractures and fusions of the hand and wrist.

Source page: https://510kreport.com/device/K192473
Methodology: https://510kreport.com/methodology