# K083772: Columbus Revision Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant System, Inc.
- Decided: Jun 4, 2009 after 168 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: 4 (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). 13 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 26 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.
- K030367: Columbus (PS), Aesculap, Inc. (2003) Summary page 1.
- K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces, Zimmer, Inc. (1996) Summary page 1.

## Most influential descendants
- K101815: Enduro Knee System (2010), 10 descendants of its own
- K130299: GMK Hinge (2013), 4 descendants of its own
- 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

## Recalls of this device
- Jan 21, 2020 · Class II · Z-1482-2020: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
- Nov 30, 2015 · Class II · Z-1043-2016: Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementle
- Sep 19, 2013 · Class II · Z-0492-2014: The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.
- Feb 21, 2012 · Class II · Z-1793-2012: During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem.

## Indications for use
The Columbus Revision 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 Revision Knee System is designed to for use with bone cement.

Source page: https://510kreport.com/device/K083772
Methodology: https://510kreport.com/methodology