Cleared Traditional

EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing

K203557 · Encore Medical, L.P. · Orthopedic

Feb 2021

Decision

65d

Days

Class 2

Risk

About This 510(k) Submission

K203557 is an FDA 510(k) clearance for the EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing, 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 February 10, 2021, 65 days after receiving the submission on December 7, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K203557 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 07, 2020
Decision Date	February 10, 2021
Days to Decision	65 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