Cleared Traditional

Initia T3 Acetabular Hemispherical Shell System

K242045 · Kyocera Medical Technologies, Inc. · Orthopedic

Apr 2025

Decision

272d

Days

Class 2

Risk

About This 510(k) Submission

K242045 is an FDA 510(k) clearance for the Initia T3 Acetabular Hemispherical Shell System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Kyocera Medical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on April 10, 2025, 272 days after receiving the submission on July 12, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K242045 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2024
Decision Date	April 10, 2025
Days to Decision	272 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358