Cleared Traditional

Mfinity Femoral System

K251166 · Medacta International S.A. · Orthopedic

Jun 2025

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K251166 is an FDA 510(k) clearance for the Mfinity Femoral System, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on June 13, 2025, 59 days after receiving the submission on April 15, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K251166 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 2025
Decision Date	June 13, 2025
Days to Decision	59 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