510(k) · Cleared
ClearedEVOLUTION® Cement Keel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 31, 2023 as substantially equivalent to K162026 (Microport Orthopedics, Inc., 2017) after a 123-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Oct 31, 2023
- Review
- 123 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K043083 (2005). No later device cites it as a predicate yet.
- Root · 4 generations backK043083 Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular…Wrightmedicaltechnologyinc · 2005
- 3 generations backK143366 ADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc. · 2015
- 2 generations backK152298 EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE…Microport Orthopedics, Inc. · 2015
- 1 generation backK162026 EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block…Microport Orthopedics, Inc. · 2017
- This deviceK231947 EVOLUTION® Cement KeelMicroport Orthopedics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K043083 | Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel | Wrightmedicaltechnologyinc | 2005 | — |
| −3 | K143366 | ADVANCE Porous Coated Spiked Tibial Base | Microport Orthopedics, Inc. | 2015 | — |
| −2 | K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels… | Microport Orthopedics, Inc. | 2015 | — |
| −1 | K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment… | Microport Orthopedics, Inc. | 2017 | — |
| 0 (this device) | K231947 | EVOLUTION® Cement Keel | Microport Orthopedics, Inc. | 2023 | — |
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 |
|---|---|---|---|
| * | K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION…Summary page 5…Class II Subject Product Code and Orthopedics/87/JWH Panel Code: Predicate Device: EVOLUTION® Revision Tibial System, K162026 Page 1 of 4… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K162026.
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. 2023, 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?
The EVOLUTION® Cement Keel is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
The EVOLUTION® Cement Keels are for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231947: EVOLUTION® Cement Keel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231947
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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