Cleared Traditional

EMPOWR Porous Femur with HAnano SurfaceTM

K210308 · Encore Medical, L.P. · Orthopedic

Mar 2021

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K210308 is an FDA 510(k) clearance for the EMPOWR Porous Femur with HAnano SurfaceTM, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on March 30, 2021, 55 days after receiving the submission on February 3, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K210308 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2021
Decision Date	March 30, 2021
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565