# K232114: TRIBRID® Unicompartmental Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Kyocera Medical Technologies, Inc.
- Decided: Apr 4, 2024 after 265 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K810258 (1981). 102 ancestors in all.
No later device cites it as a predicate yet.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190085: Journey II Unicompartmental Knee System, Smith & Nephew, Inc. (2019) Summary page 5.

## Indications for use
The Kyocera TRIBRID@ Unicompartmental Knee System is indicated for use in patients with the following: Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, or idiopathic osteonecrosis, of either the medial or lateral compartments. Correction of varus, valgus, or posttraumatic deformity. As an alternative to tibial osteotomy in patients with unicompartmental NIDJD disease. Revision procedures where other treatments or devices have failed. This device is intended for cemented use only.

Source page: https://510kreport.com/device/K232114
Methodology: https://510kreport.com/methodology