Cleared Traditional

EMPOWR Universal Tibial Baseplate

K173723 · Encore Medical, L.P. · Orthopedic

Mar 2018

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K173723 is an FDA 510(k) clearance for the EMPOWR Universal Tibial Baseplate, 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 March 5, 2018, 90 days after receiving the submission on December 5, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K173723 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2017
Decision Date	March 05, 2018
Days to Decision	90 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