510(k) · Cleared
ClearedConsensus Revision Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consensus Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jun 24, 2010 after a 119-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- Jun 24, 2010
- Review
- 119 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 5 citing it directly.
- This deviceK100542 Consensus Revision Knee SystemConsensus Orthopedics, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK133919 Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK163167 CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK143725 Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK160515 PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014 · cites it directly7descendants
- K163167CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017 · cites it directly3descendants
- K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc. · 2015 · cites it directly3descendants
- K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019 · 2 generations on2descendants
- K160515PS2 Knee SystemConsensus Orthopedics, Inc. · 2016 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100542 | Consensus Revision Knee System | Consensus Orthopedics, Inc. | 2010 | — |
| +1 | K133919 | Consensus Vitalite Tibial Insert | Consensus Orthopedics, Inc. | 2014 | — |
| +1 | K163167 | CKS Plus Knee System | Consensus Orthopedics, Inc. | 2017 | — |
| +1 | K143725 | Consensus Knee System Modular Tibial Baseplate | Consensus Orthopedics, Inc. | 2015 | — |
| +2 | K191765 | OMNI TiN Coated Apex Knee™ System | Omni Life Science, Inc. | 2019 | — |
| +1 | K160515 | PS2 Knee System | Consensus Orthopedics, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
5 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, K133919 (Consensus Orthopedics, Inc., 2014) has gone furthest, with 7 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 | — |
What is it indicated for?
A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle. B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy) C. Failed osteotomy or unicompartmental replacements. 0. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock…
Read the full statement (110 words)
A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy)
C. Failed osteotomy or unicompartmental replacements.
0. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery
F. Moderate valgus, varus, or flexion deformities
G. All CONSENSUS® RKS femoral components and tibia] baseplates are intended FOR CEMENTED USE ONLY.
H. All CONSENSUS® RKS stems are intended FOR PRESS-FIT NON-CEMENTED USE.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K100542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100542: Consensus Revision 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/K100542
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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