510(k) · Cleared
Recalled · Class II · 2020Columbus (PS)
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 Aug 21, 2003 as substantially equivalent to K021313 (Aesculap, Inc., 2002) and 4 other predicates after a 198-day review. Its family tree reaches back 3 generations to 1992. 17 later devices descend from it. It has been recalled once.
- Decided
- Aug 21, 2003
- Review
- 198 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 3 generations to K915192 (1992). 11 ancestors in all. 17 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 deviceK030367 Columbus (PS)Aesculap, Inc. · 2003
- Descendant · cites it directly · 12 of its ownK083772 Columbus Revision Knee SystemAesculap Implant System, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 10 of its ownK101815 Enduro Knee SystemAesculap Implant Systems · 2010
- Descendant · cites it directly · 7 of its ownK071220 Columbus Total Knee System asAesculap Implant Systems, Inc. · 2007 · Recalled
- Descendant · cites it directly · 4 of its ownK143106 VEGA Knee SystemAesculap Implant Systems, LLC · 2014
- Descendant · 3 generations on · 4 of its ownK130299 GMK HingeMedacta International · 2013 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K083772Columbus Revision Knee SystemAesculap Implant System, Inc. · 2009 · cites it directly12descendants
- K101815Enduro Knee SystemAesculap Implant Systems · 2010 · 2 generations on10descendants
- K071220Columbus Total Knee System asAesculap Implant Systems, Inc. · 2007 · cites it directly7descendants
- K143106VEGA Knee SystemAesculap Implant Systems, LLC · 2014 · cites it directly4descendants
- K130299GMK HingeMedacta International · 2013 · 3 generations on4descendants
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) | K030367 | Columbus (PS) | Aesculap, Inc. | 2003 | — |
| +1 | K083772 | Columbus Revision Knee System | Aesculap Implant System, Inc. | 2009 | 4 |
| +2 | K101815 | Enduro Knee System | Aesculap Implant Systems | 2010 | — |
| +1 | K071220 | Columbus Total Knee System as | Aesculap Implant Systems, Inc. | 2007 | 1 |
| +1 | K143106 | VEGA Knee System | Aesculap Implant Systems, LLC | 2014 | — |
| +3 | K130299 | GMK Hinge | Medacta International | 2013 | 2 |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2025 | 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? (5)
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 SystemSummary page 2…the market. SUBSTANTIAL EQUIVALENCE AesculapB', Inc. believes that the Columbus Total Knee System is substantially equivalent to: 0 Search Evolution Total Knee System (K021313) 0 Scorpio PS Knee System (K962152) 0 Scorpio Total Stabilizer (KO994128) Gem Knee System (K994214) 0 Gem PS Total Kne… | 2002 |
| * | K962152 | Osteonics Scorpio Posteriorly Stabilized Total Knee SystemSummary page 2…esculapB', Inc. believes that the Columbus Total Knee System is substantially equivalent to: 0 Search Evolution Total Knee System (K021313) 0 Scorpio PS Knee System (K962152) 0 Scorpio Total Stabilizer (KO994128) Gem Knee System (K994214) 0 Gem PS Total Knee System (K010101)… | 1996 |
| * | K994128 | Scorpio Total Stablizer (TS) Total Knee SystemSummary page 2…Total Knee System is substantially equivalent to: 0 Search Evolution Total Knee System (K021313) 0 Scorpio PS Knee System (K962152) 0 Scorpio Total Stabilizer (KO994128) Gem Knee System (K994214) 0 Gem PS Total Knee System (K010101) DEPARTMENT OF HEALTH 8%HUMAN SERVICES… | 2000 |
| * | K994214 | Gem Knee SystemSummary page 2…tially equivalent to: 0 Search Evolution Total Knee System (K021313) 0 Scorpio PS Knee System (K962152) 0 Scorpio Total Stabilizer (KO994128) Gem Knee System (K994214) 0 Gem PS Total Knee System (K010101) DEPARTMENT OF HEALTH 8%HUMAN SERVICES… | 2000 |
| * | K010101 | Gem Posterior Stabilized Total Knee SystemSummary page 2…ion Total Knee System (K021313) 0 Scorpio PS Knee System (K962152) 0 Scorpio Total Stabilizer (KO994128) Gem Knee System (K994214) 0 Gem PS Total Knee System (K010101) DEPARTMENT OF HEALTH 8%HUMAN SERVICES Public Health Service… | 2001 |
What descends from it? (17)
See all 173 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 21, 2020 | Class II | Z-1479-2020 | Material/Component Contamination | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 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, K083772 (Aesculap Implant System, Inc., 2009) has gone furthest, with 12 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 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030367 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030367: Columbus (PS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030367
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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