# K122985: Columbus Revision Knee System

- Pathway: 510(k) (Special)
- Applicant: Aesculap Implant System, Inc.
- Decided: Oct 26, 2012 after 30 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K915192 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083772: Columbus Revision Knee System, Aesculap Implant System, Inc. (2009) Summary page 1.

## Recalls of this device
- Sep 19, 2013 · Class II · Z-0492-2014: The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.

## Indications for use
The Columbus REVISION 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 REVISION Knee System is designed to for use with bone cement.

Source page: https://510kreport.com/device/K122985
Methodology: https://510kreport.com/methodology