# K974030: Carpal Engaging Wrist Fusion Plate

- Pathway: 510(k) (Traditional)
- Applicant: Terray Corp.
- Decided: Jan 21, 1998 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The various clinical indications for wrist arthrodesns are at the discretion of the surgeon but in general include: ° rheumatoid wrist deformities\'rcquiring restoration of alignment and stability . carpal instabilities o severe unremitting wrist pain related to motion of the carpus ‘ . other damage to the wrist joint including post-traumatic arthrosis, infection and tumor resection.

Source page: https://510kreport.com/device/K974030
Methodology: https://510kreport.com/methodology