510(k) · Cleared
ClearedEVOLUTION MP Revision Femur, EVOLUTION Femoral Augments
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 Nov 7, 2014 as substantially equivalent to K932677 (Orthomet, Inc., 1994) after a 58-day review. Its family tree reaches back 1 generation to 1994. 8 later devices descend from it.
- Decided
- Nov 7, 2014
- Review
- 58 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932677 (1994). 8 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK932677 Axiom Total Knee SystemOrthomet, Inc. · 1994
- This deviceK142550 EVOLUTION MP Revision Femur, EVOLUTION Femoral AugmentsMicroport Orthopedics, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK182125 EVOLUTION Stemmed CS FemurMicroport Orthopedics, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK171389 EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK253728 EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK240043 EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW…Microport Orthopedics, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K182125EVOLUTION Stemmed CS FemurMicroport Orthopedics, Inc. · 2018 · cites it directly3descendants
- K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017 · cites it directly3descendants
- K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025 · 2 generations on1descendant
- K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026 · 3 generations on0descendants
- K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932677 | Axiom Total Knee System | Orthomet, Inc. | 1994 | — |
| 0 (this device) | K142550 | EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments | Microport Orthopedics, Inc. | 2014 | — |
| +1 | K182125 | EVOLUTION Stemmed CS Femur | Microport Orthopedics, Inc. | 2018 | — |
| +1 | K171389 | EVOLUTION Revision CCK System | Microport Orthopedics, Inc. | 2017 | — |
| +2 | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and… | Microport Orthopedics, Inc. | 2025 | — |
| +3 | K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026 | — |
| +2 | K240043 | EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal… | Microport Orthopedics, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K932677 | Axiom Total Knee SystemSummary page 4…Class II Subject Product Code and Panel Code: Orthopedics/87/JWH Predicate Device: AXIOM® Stemmed Femoral Component (K932677) Reference Devices: ADVANCE® Femoral Augments (K990030) ADVANCE… | 1994 |
| † | K990030 | Advanced Revision Product Line Extension | 1999 |
| † | K061223 | Advance Total Knee System | 2006 |
| † | K093552 | Evolution MP Total Knee System | 2010 |
| † | K102380 | Evolution MP Total Knee System | 2011 |
| † | K140735 | Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts | 2014 |
What descends from it? (8)
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?
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. 2014, 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® MP Revision Femoral System 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 discase, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that arc unmanageable using other techniques.
The EVOLUTION® MP Revision Femoral System is for cemented use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142550: EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142550
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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