Cleared Traditional

EMPOWR Knee

K252974 · Encore Medical, L.P. · Orthopedic

Dec 2025

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K252974 is an FDA 510(k) clearance for the EMPOWR 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 December 19, 2025, 93 days after receiving the submission on September 17, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K252974 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 2025
Decision Date	December 19, 2025
Days to Decision	93 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