# K172425: OrthoPediatrics Wrist Fusion Plate

- Pathway: 510(k) (Traditional)
- Applicant: Orthopediatrics, Inc.
- Decided: Dec 6, 2017 after 118 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 K042355 (2004). 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)
- K042355: Synthes (Usa) LCP Wrist Fusion Plates, Synthes (Usa) (2004) Summary page 4.
- K093474: Depuy Fracture and Fusion Plating System, DePuy Orthopaedics, Inc. (2010) Summary page 4.

## Indications for use
OrthoPediatrics Wrist Fusion Plates are intended for wrist arthrodesis and fractures of other small bones in children, adolescents, and small stature adults. 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 pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities.

Source page: https://510kreport.com/device/K172425
Methodology: https://510kreport.com/methodology