Cleared Traditional

TRIBRID? Unicompartmental Knee System

K232114 · Kyocera Medical Technologies, Inc. · Orthopedic

Apr 2024

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K232114 is an FDA 510(k) clearance for the TRIBRID? Unicompartmental Knee System, a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Kyocera Medical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on April 4, 2024, 265 days after receiving the submission on July 14, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K232114 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 2023
Decision Date	April 04, 2024
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3520