Cleared Traditional

EMPOWR VVC TIBIAL INSERT

K180930 · Encore Medical, L.P. · Orthopedic

Jul 2018

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K180930 is an FDA 510(k) clearance for the EMPOWR VVC TIBIAL INSERT, 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 July 9, 2018, 90 days after receiving the submission on April 10, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K180930 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2018
Decision Date	July 09, 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