# K071499: Columbus Total Knee System Mios CR/PS Tibial Tray

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: Sep 14, 2007 after 106 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). 17 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 24 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.
- K032829: Scorpio Low Profile Tibial Tray, Howmedica Osteonics Corp. (2003) Summary page 1.
- K853661: Millar/Galante Precoated Total Knee, Zimmer, Inc. (1985) Summary page 1.

## Most influential descendants
- 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
- K081293: Univation Unicondylar Knee System (2008), 1 descendant 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

## 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 is designed for use with bone cement.

Source page: https://510kreport.com/device/K071499
Methodology: https://510kreport.com/methodology