# K120955: Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Dec 17, 2012 after 262 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: 6 generations back to K915192 (1992). 35 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071220: Columbus Total Knee System as, Aesculap Implant Systems, Inc. (2007) Summary page 1.
- K053390: Columbus (CR) Total Knee System, Aesculap, Inc. (2006) Summary page 1.
- K101815: Enduro Knee System, Aesculap Implant Systems (2010) Summary page 3.

## 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
- 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 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. The EnduRo 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. Hinge knee systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws. The EnduRo Knee System is intended for cemented use only.

Source page: https://510kreport.com/device/K120955
Methodology: https://510kreport.com/methodology