Cleared Traditional

EMPOWR Revision Knee

K213793 · Encore Medical, L.P. · Orthopedic

Apr 2022

Decision

116d

Days

Class 2

Risk

About This 510(k) Submission

K213793 is an FDA 510(k) clearance for the EMPOWR Revision Knee, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on April 1, 2022, 116 days after receiving the submission on December 6, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K213793 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2021
Decision Date	April 01, 2022
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560