# K023788: Columbus (CR) Total Knee System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Dec 13, 2002 after 30 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: 3 generations back to K915192 (1992). 11 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021313: Search Evolution Total Knee System, Aesculap, Inc. (2002)
- K974556: Osteonics Scorpio Posterior Cruciate Retaining Total Knee System, Osteonics Corp. (1998) Summary page 2.
- K994214: Gem Knee System, Kinamed, Inc. (2000) Summary page 2.

## Most influential descendants
- K033260: Aequos (2004), 19 descendants of its own
- K141934: Physica KR Knee System (2015), 18 descendants of its own
- K190911: Physica KR Liner and SMR Reverse Humeral Liner (2019), 8 descendants of its own
- K151266: Physica CR Knee System (2015), 8 descendants of its own
- K220792: SMR Reverse Liner (2022), 7 descendants of its own

## Indications for use
The Columbus (CR)Total Knee System is intended 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 persists, 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/K023788
Methodology: https://510kreport.com/methodology