Cleared Traditional

Mpact 3D Metal Augments II

K242232 · Medacta International S.A. · Orthopedic

Apr 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K242232 is an FDA 510(k) clearance for the Mpact 3D Metal Augments II, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on April 23, 2025, 267 days after receiving the submission on July 30, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K242232 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2024
Decision Date	April 23, 2025
Days to Decision	267 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