Cleared Traditional

MobileLink Acetabular Cup System - inhouse coatings

K243927 · Waldemar Link GmbH & Co. KG · Orthopedic

May 2025

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K243927 is an FDA 510(k) clearance for the MobileLink Acetabular Cup System - inhouse coatings, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Waldemar Link GmbH & Co. KG (Norderstedt, DE). The FDA issued a Cleared decision on May 16, 2025, 147 days after receiving the submission on December 20, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K243927 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2024
Decision Date	May 16, 2025
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353