510(k) · Cleared
Recalled · 2006VKS Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 18, 2002 as substantially equivalent to K000666 (Plus Orthopedics, 2000) after a 105-day review. Its family tree reaches back 2 generations to 1993. 70 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 18, 2002
- Review
- 105 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923277 (1993). 70 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK923277 Foundation Knee SystemEncore Orthopedics, Inc. · 1993 · Recalled
- 1 generation backK000666 TC-Plus Solution KneePlus Orthopedics · 2000 · Recalled
- This deviceK022204 VKS Knee SystemPlus Orthopedics · 2002
- Descendant · cites it directly · 53 of its ownK072858 TC-Plus Primary Knee SystemSmith & Nephew, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- Descendant · 3 generations on · 34 of its ownK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- Descendant · 3 generations on · 28 of its ownK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- Descendant · 3 generations on · 23 of its ownK113571 GMK Resufacing Patella Size 4Medacta International · 2012
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K072858TC-Plus Primary Knee SystemSmith & Nephew, Inc. · 2007 · cites it directly53descendants
- K090988GMK Total Knee SystemMedacta International S.A. · 2009 · 2 generations on52descendants
- K102437GMK Revision Knee SystemMedacta International S.A. · 2010 · 3 generations on34descendants
- K103170GMK Revision Knee SC LinersMedacta International S.A. · 2011 · 3 generations on28descendants
- K113571GMK Resufacing Patella Size 4Medacta International · 2012 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923277 | Foundation Knee System | Encore Orthopedics, Inc. | 1993 | 4 |
| −1 | K000666 | TC-Plus Solution Knee | Plus Orthopedics | 2000 | 9 |
| 0 (this device) | K022204 | VKS Knee System | Plus Orthopedics | 2002 | — |
| +1 | K072858 | TC-Plus Primary Knee System | Smith & Nephew, Inc. | 2007 | 15 |
| +2 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| +3 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| +3 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| +3 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 9 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K000666 | TC-Plus Solution KneeSummary page 1…ented, PoIy me r/MetaI/Poly me r. 5 21 CFR 888.3560, Class II, 87 JWH Equivalence: TC-PLUSTMSolution Knee System (K000666, SE date 10/13/2000) Characteristics: The VKS Knee System is a tri-compartmental total knee prosthesis… | 2000 |
What descends from it? (70)
See all 705 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 |
|---|---|---|---|---|
| Nov 13, 2006 | Not classified | Z-0361-2008 | Employee error | Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert. |
| Dec 2, 2005 | Not classified | Z-0397-06 | Other | The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happend during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during… |
| Jun 3, 2005 | Not classified | Z-0924-05 | Other | Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long. |
| Jan 4, 2005 | Not classified | Z-0540-05 | Other | Knee tibial insert is mislabeled completely as different device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K072858 (Smith & Nephew, Inc., 2007) has gone furthest, with 53 descendants of its own.
- 4 other devices also cite its predicate K000666.
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.
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 VKS Knee System is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is not indicated when significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision, or connective tissue disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022204: VKS 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/K022204
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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