510(k) · Cleared
Recalled · Class II · 2013Columbus Revision Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant System, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 26, 2012 as substantially equivalent to K083772 (Aesculap Implant System, Inc., 2009) after a 30-day review. Its family tree reaches back 5 generations to 1992. It has been recalled once.
- Decided
- Oct 26, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K915192 (1992). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
- 4 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
- 3 generations backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
- 2 generations backK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
- 1 generation backK083772 Columbus Revision Knee SystemAesculap Implant System, Inc. · 2009 · Recalled
- This deviceK122985 Columbus Revision Knee SystemAesculap Implant System, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915192 | 7000 Series Modular Tibial Components | Osteonics Corp. | 1992 | — |
| −4 | K994128 | Scorpio Total Stablizer (TS) Total Knee System | Howmedica Osteonics Corp. | 2000 | 8 |
| −3 | K021313 | Search Evolution Total Knee System | Aesculap, Inc. | 2002 | — |
| −2 | K022672 | Columbus Total Knee System (CR) | Aesculap, Inc. | 2002 | 1 |
| −1 | K083772 | Columbus Revision Knee System | Aesculap Implant System, Inc. | 2009 | 4 |
| 0 (this device) | K122985 | Columbus Revision Knee System | Aesculap Implant System, Inc. | 2012 | — |
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 |
| 2003 | 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? (1)
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 |
|---|---|---|---|
| * | K083772 | Columbus Revision Knee SystemSummary page 1…he modification to Columbus REVISION Knee System remains substantially equivalent to Aesculap Implant Systems Columbus REVISION Knee System originally cleared in 510O(K) K083772. DEVICE DESCRIPTION The cemented Columbus REVISION Knee System is a semi-constrained cemented prosthesis system. The system offe… | 2009 |
| † | K071220 | Columbus Total Knee System as | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2013 | Class II | Z-0492-2014 | Component change control | The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 8 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K083772.
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. 2012, this device’s year, is highlighted.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122985 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122985: Columbus Revision 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/K122985
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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