Cleared Traditional

EMPOWR Acetabular? Liner Extension

K251833 · Encore Medical, L.P. · Orthopedic

Nov 2025

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K251833 is an FDA 510(k) clearance for the EMPOWR Acetabular? Liner Extension, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on November 12, 2025, 149 days after receiving the submission on June 16, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K251833 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2025
Decision Date	November 12, 2025
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358