Cleared Traditional

LINK MobileLink Acetabular Cup System

K222066 · Waldemar Link GmbH & Co. KG · Orthopedic

Apr 2023

Decision

275d

Days

Class 2

Risk

About This 510(k) Submission

K222066 is an FDA 510(k) clearance for the LINK MobileLink Acetabular Cup System, 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 April 14, 2023, 275 days after receiving the submission on July 13, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K222066 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2022
Decision Date	April 14, 2023
Days to Decision	275 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