510(k) · Cleared
ClearedConsensus (TM) Knee Cobalt Chrome Nonporous Stemmed Tibial Baseplate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U.S. Medical Products, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on May 31, 1995 after a 198-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- May 31, 1995
- Review
- 198 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK945589 Consensus (TM) Knee Cobalt Chrome Nonporous Stemmed Tibial BaseplateU.S. Medical Products, Inc. · 1995
- 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
- Descendant · 2 generations on · 1 of its ownK191084 The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945589 | Consensus (TM) Knee Cobalt Chrome Nonporous Stemmed Tibial Baseplate | U.S. Medical Products, Inc. | 1995 | — |
| +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 | — |
| +2 | K191084 | The Optimotion Blue Total Knee System | Optimotion Implants, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 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), 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? (10)
4 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, K163167 (Consensus Orthopedics, Inc., 2017) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K945589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945589: Consensus (TM) Knee Cobalt Chrome Nonporous Stemmed Tibial Baseplate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945589
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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