Cleared Traditional

Mpact 3D Metal Implants Extension ? DMLS Technology

K251043 · Medacta International S.A. · Orthopedic

Jan 2026

Decision

300d

Days

Class 2

Risk

About This 510(k) Submission

K251043 is an FDA 510(k) clearance for the Mpact 3D Metal Implants Extension ? DMLS Technology, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Medacta International S.A. (San Pietro, CH). The FDA issued a Cleared decision on January 28, 2026, 300 days after receiving the submission on April 3, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K251043 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2025
Decision Date	January 28, 2026
Days to Decision	300 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