# K150544: Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System

- Pathway: 510(k) (Special)
- Applicant: Aesculap Implant Systems, LLC
- Decided: May 29, 2015 after 87 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: 1 generation back to K101281 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101281: Vega Knee System, Aesculap Implant System, Inc. (2010) Summary page 4.

## Indications for use
Columbus Total Knee System, Columbus Revision Knee and EnduRo Knee System are 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. Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint. 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 Columbus Total Knee System, Columbus Revision Knee System and EnduRo Knee System are designed for use with bone cement.

Source page: https://510kreport.com/device/K150544
Methodology: https://510kreport.com/methodology