Cleared Traditional

Alteon? HA Femoral Stems

K243839 · Exactech, Inc. · Orthopedic

Mar 2025

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K243839 is an FDA 510(k) clearance for the Alteon? HA Femoral Stems, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on March 10, 2025, 87 days after receiving the submission on December 13, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K243839 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2024
Decision Date	March 10, 2025
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353