# K053579: Columbus Ultra Congruent (UC) Tibial Insert/Gliding Surface

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: May 17, 2006 after 146 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915192 (1992). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022672: Columbus Total Knee System (CR), Aesculap, Inc. (2002) Summary page 1.
- K023788: Columbus (CR) Total Knee System, Aesculap, Inc. (2002) Summary page 1.
- K022204: VKS Knee System, Plus Orthopedics (2002) Summary page 1.

## Indications for use
The Columbus (CR) Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. The Columbus Knee (CR) is designed for use with bone cement.

Source page: https://510kreport.com/device/K053579
Methodology: https://510kreport.com/methodology