510(k) · Cleared
ClearedColumbus (CR) Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Dec 13, 2002 as substantially equivalent to K021313 (Aesculap, Inc., 2002) and 2 other predicates after a 30-day review. Its family tree reaches back 3 generations to 1992. 25 later devices descend from it.
- Decided
- Dec 13, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K915192 (1992). 11 ancestors in all. 25 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
- 2 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
- 1 generation backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
- This deviceK023788 Columbus (CR) Total Knee SystemAesculap, Inc. · 2002
- Descendant · cites it directly · 19 of its ownK033260 AequosAap Implantate AG · 2004
- Descendant · 2 generations on · 18 of its ownK141934 Physica KR Knee SystemLima Corporate S.P.A. · 2015
- Descendant · 3 generations on · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
- Descendant · 3 generations on · 8 of its ownK151266 Physica CR Knee SystemLima Corporate S.P.A. · 2015
- Descendant · 4 generations on · 7 of its ownK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K033260AequosAap Implantate AG · 2004 · cites it directly19descendants
- K141934Physica KR Knee SystemLima Corporate S.P.A. · 2015 · 2 generations on18descendants
- K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · 3 generations on8descendants
- K151266Physica CR Knee SystemLima Corporate S.P.A. · 2015 · 3 generations on8descendants
- K220792SMR Reverse LinerLima Corporate S.P.A. · 2022 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915192 | 7000 Series Modular Tibial Components | Osteonics Corp. | 1992 | — |
| −2 | K994128 | Scorpio Total Stablizer (TS) Total Knee System | Howmedica Osteonics Corp. | 2000 | 8 |
| −1 | K021313 | Search Evolution Total Knee System | Aesculap, Inc. | 2002 | — |
| 0 (this device) | K023788 | Columbus (CR) Total Knee System | Aesculap, Inc. | 2002 | — |
| +1 | K033260 | Aequos | Aap Implantate AG | 2004 | — |
| +2 | K141934 | Physica KR Knee System | Lima Corporate S.P.A. | 2015 | — |
| +3 | K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | 2019 | — |
| +3 | K151266 | Physica CR Knee System | Lima Corporate S.P.A. | 2015 | — |
| +4 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021313 | Search Evolution Total Knee System | 2002 |
| * | K974556 | Osteonics Scorpio Posterior Cruciate Retaining Total Knee SystemSummary page 2…lumbus Total Knee System is substantially equivalent to: Search Evolution Total Knee System (KO21313) 0 Scorpio Posterior Cruciate Retaining Knee System (K974556) Gem Knee System (K994214) ,."' a B <$ 'sa- Ir DEPARTMENT OF HEALTH… | 1998 |
| * | K994214 | Gem Knee SystemSummary page 2…tially equivalent to: Search Evolution Total Knee System (KO21313) 0 Scorpio Posterior Cruciate Retaining Knee System (K974556) Gem Knee System (K994214) ,."' a B <$ 'sa- Ir DEPARTMENT OF HEALTH 8r HUMAN SERVICES… | 2000 |
What descends from it? (25)
See all 253 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K033260 (Aap Implantate AG, 2004) has gone furthest, with 19 descendants of its own.
- 4 other devices also cite its predicate K021313.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023788 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023788: Columbus (CR) Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023788
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026