Cleared Traditional

Allure Hip Stem and Intramedullary Plugs

K250375 · Waldemar Link GmbH & Co. KG · Orthopedic

Nov 2025

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K250375 is an FDA 510(k) clearance for the Allure Hip Stem and Intramedullary Plugs, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Waldemar Link GmbH & Co. KG (Hamburg, DE). The FDA issued a Cleared decision on November 5, 2025, 268 days after receiving the submission on February 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K250375 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 10, 2025
Decision Date	November 05, 2025
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353