# K143443: VEGA Knee System, Columbus Total Knee System

- Pathway: 510(k) (Special)
- Applicant: Aesculap Implants Systems, LLC
- Decided: Mar 25, 2015 after 113 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: 7 generations back to K915192 (1992). 62 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 66 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.
- K121879: Vega Knee System, Aesculap Implant Systems (2012) Summary page 4.
- K140452: Vega Knee System, Aesculap Implant Systems (2014) Summary page 4.
- K143106: VEGA Knee System, Aesculap Implant Systems, LLC (2014) Summary page 4.
- K022672: Columbus Total Knee System (CR), Aesculap, Inc. (2002) Summary page 4.
- K023788: Columbus (CR) Total Knee System, Aesculap, Inc. (2002) Summary page 4.
- K053390: Columbus (CR) Total Knee System, Aesculap, Inc. (2006) Summary page 4.
- K071220: Columbus Total Knee System as, Aesculap Implant Systems, Inc. (2007) Summary page 4.
- K071499: Columbus Total Knee System Mios CR/PS Tibial Tray, Aesculap Implant Systems, Inc. (2007). Our reading of the summary gave K071449, FDA’s number for BRM3 Brain Monitor (Brainz Instruments, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Columbus Total Knee System”.
- K120955: Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System, Aesculap Implant Systems, LLC (2012) Summary page 4.
- K123166: Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P, Howmedica Osteonics Corp. (2013) Summary page 4.

## Most influential descendants
- 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 VEGA 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. Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint. The VEGA Knee is designed for use with bone cement. 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. Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint. The Columbus Knee is designed for use with bone cement.

Source page: https://510kreport.com/device/K143443
Methodology: https://510kreport.com/methodology