Cleared Traditional

Mpact Double Mobility System

K143453 · Medacta International · Orthopedic

Mar 2015

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K143453 is an FDA 510(k) clearance for the Mpact Double Mobility System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Medacta International (Castel San Pietro, CH). The FDA issued a Cleared decision on March 2, 2015, 89 days after receiving the submission on December 3, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K143453 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 03, 2014
Decision Date	March 02, 2015
Days to Decision	89 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