Cleared Special

EMPOWR Revision Knee? (EMPOWR Revision VVC+, e+ Tibial Insert)

K251776 · Encore Medical, L.P. · Orthopedic

Jul 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K251776 is an FDA 510(k) clearance for the EMPOWR Revision Knee? (EMPOWR Revision VVC+, e+ 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 8, 2025, 28 days after receiving the submission on June 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K251776 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 2025
Decision Date	July 08, 2025
Days to Decision	28 days
Submission Type	Special
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