510(k) · Cleared
Recalled · Class II · 2020Columbus 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 Jun 4, 2009 as substantially equivalent to K022672 (Aesculap, Inc., 2002) and 2 other predicates after a 168-day review. Its family tree reaches back 4 generations to 1992. 12 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 4, 2009
- Review
- 168 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 4 generations to K915192 (1992). 13 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
- 3 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
- 2 generations backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
- 1 generation backK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
- This deviceK083772 Columbus Revision Knee SystemAesculap Implant System, Inc. · 2009
- Descendant · cites it directly · 10 of its ownK101815 Enduro Knee SystemAesculap Implant Systems · 2010
- Descendant · 2 generations on · 4 of its ownK130299 GMK HingeMedacta International · 2013 · Recalled
- Descendant · 2 generations on · 4 of its ownK120955 Columbus Total Knee System as Columbus Revision Knee System Enduro…Aesculap Implant Systems, LLC · 2012
- Descendant · 3 generations on · 3 of its ownK143443 VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015
- Descendant · 2 generations on · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K101815Enduro Knee SystemAesculap Implant Systems · 2010 · cites it directly10descendants
- K130299GMK HingeMedacta International · 2013 · 2 generations on4descendants
- K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC · 2012 · 2 generations on4descendants
- K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015 · 3 generations on3descendants
- K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915192 | 7000 Series Modular Tibial Components | Osteonics Corp. | 1992 | — |
| −3 | K994128 | Scorpio Total Stablizer (TS) Total Knee System | Howmedica Osteonics Corp. | 2000 | 8 |
| −2 | K021313 | Search Evolution Total Knee System | Aesculap, Inc. | 2002 | — |
| −1 | K022672 | Columbus Total Knee System (CR) | Aesculap, Inc. | 2002 | 1 |
| 0 (this device) | K083772 | Columbus Revision Knee System | Aesculap Implant System, Inc. | 2009 | — |
| +1 | K101815 | Enduro Knee System | Aesculap Implant Systems | 2010 | — |
| +2 | K130299 | GMK Hinge | Medacta International | 2013 | 2 |
| +2 | K120955 | Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System | Aesculap Implant Systems, LLC | 2012 | — |
| +3 | K143443 | VEGA Knee System, Columbus Total Knee System | Aesculap Implants Systems, LLC | 2015 | — |
| +2 | K191765 | OMNI TiN Coated Apex Knee™ System | Omni Life Science, Inc. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K022672 | Columbus Total Knee System (CR)Summary page 1…culap Implant Systems®, Inc. believes that the Columbus Revision Knee System is substantially equivalent to: * Aesculap's Columbus Total Knee System CR/PS (K022672/K030367), * Zimmer's NexGen Complete Knee Solution Legacy Constrained Condylar Knee (K960279) DEVICE… | 2002 |
| * | K030367 | Columbus (PS)Summary page 1…plant Systems®, Inc. believes that the Columbus Revision Knee System is substantially equivalent to: * Aesculap's Columbus Total Knee System CR/PS (K022672/K030367), * Zimmer's NexGen Complete Knee Solution Legacy Constrained Condylar Knee (K960279) DEVICE DESCRIP… | 2003 |
| * | K960279 | Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral…Summary page 1…Aesculap's Columbus Total Knee System CR/PS (K022672/K030367), * Zimmer's NexGen Complete Knee Solution Legacy Constrained Condylar Knee (K960279) DEVICE DESCRIPTION The cemented Columbus Revision Knee System is a fixed prosthesis system that is available with one femoral d… | 1996 |
What descends from it? (12)
See all 122 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-1482-2020 | Material/Component Contamination | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging. |
| Nov 30, 2015 | Class II | Z-1043-2016 | Packaging change control | Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US… |
| 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. |
| Feb 21, 2012 | Class II | Z-1793-2012 | Nonconforming Material/Component | During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 7 of the 13 ancestors have a recall of any class.
- Of its descendants, K101815 (Aesculap Implant Systems, 2010) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K022672.
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. 2009, 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/K083772 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083772: Columbus Revision Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083772
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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