Cleared Traditional

DJO Acetabular System

K190057 · Encore Medical, L.P. · Orthopedic

Jun 2019

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K190057 is an FDA 510(k) clearance for the DJO Acetabular System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on June 7, 2019, 147 days after receiving the submission on January 11, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K190057 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 2019
Decision Date	June 07, 2019
Days to Decision	147 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