Cleared Traditional

MobileLink Acetabular Cup System - Line Extension (Multiple)

K241636 · Waldemar Link GmbH & Co. KG · Orthopedic

Nov 2024

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K241636 is an FDA 510(k) clearance for the MobileLink Acetabular Cup System - Line Extension (Multiple), a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Waldemar Link GmbH & Co. KG (Norderstedt, DE). The FDA issued a Cleared decision on November 8, 2024, 155 days after receiving the submission on June 6, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K241636 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2024
Decision Date	November 08, 2024
Days to Decision	155 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