510(k) · Cleared
ClearedConsensus Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hayes Medical, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Aug 7, 2000 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 56 later devices descend from it.
- Decided
- Aug 7, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
56 later devices descend from it, 7 citing it directly.
- This deviceK001456 Consensus Knee SystemHayes Medical, Inc. · 2000
- Descendant · cites it directly · 42 of its ownK090705 Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · Recalled
- Descendant · 2 generations on · 33 of its ownK112906 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012
- Descendant · 3 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
- Descendant · 3 generations on · 24 of its ownK153310 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015
- Descendant · 3 generations on · 24 of its ownK153075 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · cites it directly42descendants
- K112906Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012 · 2 generations on33descendants
- K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 3 generations on27descendants
- K153310Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · 3 generations on24descendants
- K153075Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001456 | Consensus Knee System | Hayes Medical, Inc. | 2000 | — |
| +1 | K090705 | Balanced Knee System Ultracongruent Tibial Insert | Ortho Development Corp. | 2009 | 1 |
| +2 | K112906 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2012 | — |
| +3 | K140942 | Klassic Knee Tibial Stem Extension | Total Joint Orthopedics, Inc. | 2014 | — |
| +3 | K153310 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2015 | — |
| +3 | K153075 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 8 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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? (56)
See all 567 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090705 | Balanced Knee System Ultracongruent Tibial Insert | 2009 | 42 |
| K163167 | CKS Plus Knee System | 2017 | 3 |
| K143725 | Consensus Knee System Modular Tibial Baseplate | 2015 | 3 |
| K160515 | PS2 Knee System | 2016 | 2 |
| K241180 | Consensus Knee System with TiNbN | 2025 | 1 |
| K112285 | Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated… | 2011 | 1 |
| K102927 | Consensus Knee System | 2011 | 0 |
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, K090705 (Ortho Development Corp., 2009) has gone furthest, with 42 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.
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 Consensus®Knee System and the CoCr/Ti porous or CoCr nonporous tibial baseplate is design for use as a system, and is not intended for substitution with components of other systems. This device is intended for cemented use only. The indications for use are:
Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis.
Failed osteotomy or unicompartmental replacements.
Replacement of unsatisfactory cemented or press fit knee components, if sufficient bone stock exists.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K001456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001456: Consensus 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/K001456
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026