Cleared Special

Vario-Cup System

K221794 · Waldemar Link GmbH & Co. KG · Orthopedic

Jul 2022

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K221794 is an FDA 510(k) clearance for the Vario-Cup System, a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II — Special Controls, product code KWY), submitted by Waldemar Link GmbH & Co. KG (Norderstedt, DE). The FDA issued a Cleared decision on July 20, 2022, 29 days after receiving the submission on June 21, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3390.

Submission Details

510(k) Number	K221794 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2022
Decision Date	July 20, 2022
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3390