510(k) · Cleared
ClearedColumbus Total Knee System as Columbus Revision Knee System Enduro Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, LLC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Dec 17, 2012 as substantially equivalent to K071220 (Aesculap Implant Systems, Inc., 2007) and 2 other predicates after a 262-day review. Its family tree reaches back 6 generations to 1992. 4 later devices descend from it.
- Decided
- Dec 17, 2012
- Review
- 262 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K915192 (1992). 35 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
- 5 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
- 4 generations backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
- 3 generations backK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
- 2 generations backK083772 Columbus Revision Knee SystemAesculap Implant System, Inc. · 2009 · Recalled
- 1 generation backK101815 Enduro Knee SystemAesculap Implant Systems · 2010
- This deviceK120955 Columbus Total Knee System as Columbus Revision Knee System Enduro…Aesculap Implant Systems, LLC · 2012
- Descendant · cites it directly · 3 of its ownK143443 VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015
- Descendant · cites it directly · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK252044 Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- Descendant · 2 generations on · 0 of its ownK201611 Apex Knee SystemOmnilife Science · 2021
Most influential descendants
Showing 4 of 4 · See all- K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015 · cites it directly3descendants
- K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · cites it directly2descendants
- K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 2 generations on0descendants
- K201611Apex Knee SystemOmnilife Science · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915192 | 7000 Series Modular Tibial Components | Osteonics Corp. | 1992 | — |
| −5 | K994128 | Scorpio Total Stablizer (TS) Total Knee System | Howmedica Osteonics Corp. | 2000 | 8 |
| −4 | K021313 | Search Evolution Total Knee System | Aesculap, Inc. | 2002 | — |
| −3 | K022672 | Columbus Total Knee System (CR) | Aesculap, Inc. | 2002 | 1 |
| −2 | K083772 | Columbus Revision Knee System | Aesculap Implant System, Inc. | 2009 | 4 |
| −1 | K101815 | Enduro Knee System | Aesculap Implant Systems | 2010 | — |
| 0 (this device) | K120955 | Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System | Aesculap Implant Systems, LLC | 2012 | — |
| +1 | K143443 | VEGA Knee System, Columbus Total Knee System | Aesculap Implants Systems, LLC | 2015 | — |
| +1 | K191765 | OMNI TiN Coated Apex Knee™ System | Omni Life Science, Inc. | 2019 | — |
| +2 | K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +2 | K201611 | Apex Knee System | Omnilife Science | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K071220 | Columbus Total Knee System asSummary page 1…JWH SUBSTANTIAL EQUIVALENCE The Columbus Total Knee System Alternate Surface (AS) is substantially equivalent to. Aesculap's Columbus Total Knee System (K071220) and the previously cleared Columbus Total Knee System (CRA/PSA) (K053390). DEVICE DESCRIPTION The Columbus Total Knee System AS… | 2007 |
| * | K053390 | Columbus (CR) Total Knee SystemSummary page 1…m Alternate Surface (AS) is substantially equivalent to. Aesculap's Columbus Total Knee System (K071220) and the previously cleared Columbus Total Knee System (CRA/PSA) (K053390). DEVICE DESCRIPTION The Columbus Total Knee System AS includes both "Cruciate Retaining" (CR) and "Posterior Stabilized" (PS) va… | 2006 |
| * | K101815 | Enduro Knee SystemSummary page 3…KRO SUBSTANTIAL EQUIVALENCE The EnduRo Knee System is substantially equivalent to previously cleared, Aesculap Implant Systems EnduRo Knee System (K1 01815). DEVICE DESCRIPTION The EnduRo Knee System is a cemented prosthesis with a rotating hinge design. The femoral component, tibial… | 2010 |
What descends from it? (4)
2 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 20 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 20 of the 35 ancestors have a recall of any class.
- Of its descendants, K143443 (Aesculap Implants Systems, LLC, 2015) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K071220.
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 Total 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 Knee is designed for use with bone cement. The EnduRo Knee System…
Read the full statement (171 words)
The Columbus Total 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 Knee is designed for use with bone cement.
The EnduRo 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.
Hinge knee systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
The EnduRo Knee System is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120955 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120955: Columbus Total Knee System as Columbus Revision Knee System Enduro 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/K120955
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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