510(k) · Cleared
ClearedVega Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Mar 25, 2014 as substantially equivalent to K101281 (Aesculap Implant System, Inc., 2010) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 2010. 5 later devices descend from it.
- Decided
- Mar 25, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K101281 (2010). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK101281 Vega Knee SystemAesculap Implant System, Inc. · 2010
- 1 generation backK121879 Vega Knee SystemAesculap Implant Systems · 2012
- This deviceK140452 Vega Knee SystemAesculap Implant Systems · 2014
- Descendant · cites it directly · 4 of its ownK143106 VEGA Knee SystemAesculap Implant Systems, LLC · 2014
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 0 of its ownK252044 Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- Descendant · 3 generations on · 0 of its ownK201611 Apex Knee SystemOmnilife Science · 2021
Most influential descendants
Showing 5 of 5 · See all- K143106VEGA Knee SystemAesculap Implant Systems, LLC · 2014 · cites it directly4descendants
- K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC · 2015 · cites it directly3descendants
- K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 2 generations on2descendants
- K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 3 generations on0descendants
- K201611Apex Knee SystemOmnilife Science · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K101281 | Vega Knee System | Aesculap Implant System, Inc. | 2010 | — |
| −1 | K121879 | Vega Knee System | Aesculap Implant Systems | 2012 | — |
| 0 (this device) | K140452 | Vega Knee System | Aesculap Implant Systems | 2014 | — |
| +1 | K143106 | VEGA Knee System | Aesculap Implant Systems, LLC | 2014 | — |
| +1 | 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 | — |
| +3 | K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +3 | K201611 | Apex Knee System | Omnilife Science | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K101281 | Vega Knee SystemSummary page 1…es that the optional use of compatible Columbus CRA/PSA tibial plateaus and augments (K053390; K071220 and K1 20955) are a line extension to Aesculap's VEGA Knee System (K101281 and K121879). This line extension remains substantially equivalent to the currently marketed Aesculap Implant Systems VEGA Knee S… | 2010 |
| * | K121879 | Vega Knee SystemSummary page 1…optional use of compatible Columbus CRA/PSA tibial plateaus and augments (K053390; K071220 and K1 20955) are a line extension to Aesculap's VEGA Knee System (K101281 and K121879). This line extension remains substantially equivalent to the currently marketed Aesculap Implant Systems VEGA Knee System. DEV… | 2012 |
| † | K053390 | Columbus (CR) Total Knee System | 2006 |
| † | K071220 | Columbus Total Knee System as | 2007 |
| † | K120955 | Columbus Total Knee System as Columbus Revision Knee System Enduro Knee System | 2012 |
What descends from it? (5)
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 4 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K143106 (Aesculap Implant Systems, LLC, 2014) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K101281.
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. 2014, 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 VEGA 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.
Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.
The VEGA Knee System is designed for use with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140452: Vega Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140452
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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