# K221794: Vario-Cup System

- Pathway: 510(k) (Special)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Jul 20, 2022 after 29 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K941847 (1994). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781735: Endoprosthesis System, Vario-Head, Waldemar Link GmbH & Co. KG (1978) Summary page 4.
- K060707: Aesculap Bipolar Acetabular Cup, Aesculap, Inc. (2006) Summary page 4.

## Indications for use
Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures. Femoral neck fractures. Correction of functional deformities.

Source page: https://510kreport.com/device/K221794
Methodology: https://510kreport.com/methodology