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 System, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 30, 2010 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Jul 30, 2010
- Review
- 85 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 5 citing it directly.
- This deviceK101281 Vega Knee SystemAesculap Implant System, Inc. · 2010
- Descendant · cites it directly · 14 of its ownK121879 Vega Knee SystemAesculap Implant Systems · 2012
- Descendant · 2 generations on · 7 of its ownK152008 Physica PS Knee SystemLima Corporate S.P.A. · 2015
- Descendant · 3 generations on · 6 of its ownK193284 Physica LMC Knee SystemLima Corporate S.P.A. · 2020
- Descendant · 4 generations on · 5 of its ownK201084 Physica systemLima Corporate S.P.A. · 2020
- Descendant · cites it directly · 5 of its ownK140452 Vega Knee SystemAesculap Implant Systems · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K121879Vega Knee SystemAesculap Implant Systems · 2012 · cites it directly14descendants
- K152008Physica PS Knee SystemLima Corporate S.P.A. · 2015 · 2 generations on7descendants
- K193284Physica LMC Knee SystemLima Corporate S.P.A. · 2020 · 3 generations on6descendants
- K201084Physica systemLima Corporate S.P.A. · 2020 · 4 generations on5descendants
- K140452Vega Knee SystemAesculap Implant Systems · 2014 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101281 | Vega Knee System | Aesculap Implant System, Inc. | 2010 | — |
| +1 | K121879 | Vega Knee System | Aesculap Implant Systems | 2012 | — |
| +2 | K152008 | Physica PS Knee System | Lima Corporate S.P.A. | 2015 | — |
| +3 | K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | 2020 | — |
| +4 | K201084 | Physica system | Lima Corporate S.P.A. | 2020 | — |
| +1 | K140452 | Vega Knee System | Aesculap Implant Systems | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 165 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?
- Of its descendants, K121879 (Aesculap Implant Systems, 2012) has gone furthest, with 14 descendants of its own.
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. 2010, 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 | — |
https://510kreport.com/device/K101281 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101281: Vega Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101281
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026