# K053390: Columbus (CR) Total Knee System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Feb 6, 2006 after 63 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: 4 generations back to K915192 (1992). 26 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 32 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.
- K043440: Smith & Nephew, Inc. Revision Knee System, Smith & Nephew, Inc. (2005) Summary page 1.
- K032215: VKS/TC-Plus Revision Knee, Plus Orthopedics (2003) Summary page 1.
- K023667: RT-Plus Solution & RT-Plus Modular Solution Knee, Plus Orthopedics (2002) Summary page 1.
- K032479: Howmedica Osteonics Tibial Tray Screw Hole Plugs, Howmedica Osteonics Corp. (2003) Summary page 1.

## Most influential descendants
- K120955: Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System (2012), 4 descendants of its own
- K143443: VEGA Knee System, Columbus Total Knee System (2015), 3 descendants of its own
- K191765: OMNI TiN Coated Apex Knee™ System (2019), 2 descendants of its own
- K252044: Triathlon® Total Knee System - Triathlon® Gold Femoral Components (2025), 0 descendants of its own
- K201611: Apex Knee System (2021), 0 descendants of its own

## Recalls of this device
- Jan 21, 2020 · Class II · Z-1480-2020: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

## 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/K053390
Methodology: https://510kreport.com/methodology