# K030367: Columbus (PS)

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Aug 21, 2003 after 198 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: 1 (0 Class I)
- 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.
17 later devices descend from it; 3 cite it directly.
0 of 29 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) Summary page 2.
- K962152: Osteonics Scorpio Posteriorly Stabilized Total Knee System, Osteonics Corp. (1996) Summary page 2.
- K994128: Scorpio Total Stablizer (TS) Total Knee System, Howmedica Osteonics Corp. (2000) Summary page 2.
- K994214: Gem Knee System, Kinamed, Inc. (2000) Summary page 2.
- K010101: Gem Posterior Stabilized Total Knee System, Kinamed, Inc. (2001) Summary page 2.

## Most influential descendants
- K083772: Columbus Revision Knee System (2009), 12 descendants of its own
- K101815: Enduro Knee System (2010), 10 descendants of its own
- K071220: Columbus Total Knee System as (2007), 7 descendants of its own
- K143106: VEGA Knee System (2014), 4 descendants of its own
- K130299: GMK Hinge (2013), 4 descendants of its own

## Recalls of this device
- Jan 21, 2020 · Class II · Z-1479-2020: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

## Indications for use
The Columbus Total Knee System (PS) 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 (PS) is designed to for use with bone cement

Source page: https://510kreport.com/device/K030367
Methodology: https://510kreport.com/methodology