Cleared Special

ACTIS Duofix Hip Prosthesis

K202472 · DePuy Orthopaedics, Inc. · Orthopedic

Oct 2020

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K202472 is an FDA 510(k) clearance for the ACTIS Duofix Hip Prosthesis, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 21, 2020, 54 days after receiving the submission on August 28, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K202472 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2020
Decision Date	October 21, 2020
Days to Decision	54 days
Submission Type	Special
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