Cleared Traditional

Initia Knee System

K243295 · Kyocera Medical Technologies, Inc. · Orthopedic

Jan 2025

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K243295 is an FDA 510(k) clearance for the Initia Knee System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Kyocera Medical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on January 13, 2025, 87 days after receiving the submission on October 18, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K243295 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2024
Decision Date	January 13, 2025
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560