Vario-Cup System
FDA 510(k) K221794 · Waldemar Link GmbH & Co. KG
510(k) numberK221794
Submission
- Device name
- Vario-Cup System
- Applicant
- Waldemar Link GmbH & Co. KG
Norderstedt, DE - Received
- June 21, 2022
- Decision date
- July 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
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| K191297 | iNSitu Bipolar Hip SystemKWY · Traditional | Theken Companies, LLC | 09/17/2019SE |
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| 510(k) | Device | Decision |
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| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various)LZO · Traditional | 07/06/2026SE |
| K250375 | Allure Hip Stem and Intramedullary PlugsMEH · Traditional | 11/05/2025SE |
| K243927 | MobileLink Acetabular Cup System - inhouse coatingsLZO · Traditional | 05/16/2025SE |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple)LPH · Traditional | 11/08/2024SE |
| K231445 | LINK Embrace Shoulder System - Reverse ConfigurationPHX · Traditional | 11/16/2023SE |
| K222066 | LINK MobileLink Acetabular Cup SystemLPH · Traditional | 04/14/2023SE |
| K230471 | LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceJWH · Special | 03/21/2023SE |
| K213770 | SP-CL Hip Stem and LCU Hip SystemLZO · Traditional | 09/13/2022SE |
| K211567 | BiMobile Instruments (for BiMobile Dual Mobility System)LZO · Special | 06/03/2022SE |
| K220628 | LINK Endo-Model EVO Knee SystemKRO · Traditional | 05/03/2022SE |
Questions and answers
When was Vario-Cup System cleared by the FDA?
Vario-Cup System (K221794) received a 510(k) decision of Substantially Equivalent on July 20, 2022, 29 days after the submission was received.
What is the product code of K221794?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.