510(k) · Cleared
ClearedEVOLUTION Stemmed CS Femur
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 Dec 6, 2018 as substantially equivalent to K142550 (Microport Orthopedics, Inc., 2014) after a 122-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Dec 6, 2018
- Review
- 122 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932677 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK932677 Axiom Total Knee SystemOrthomet, Inc. · 1994
- 1 generation backK142550 EVOLUTION MP Revision Femur, EVOLUTION Femoral AugmentsMicroport Orthopedics, Inc. · 2014
- This deviceK182125 EVOLUTION Stemmed CS FemurMicroport Orthopedics, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK253728 EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK213817 MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025 · cites it directly1descendant
- K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026 · 2 generations on0descendants
- K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932677 | Axiom Total Knee System | Orthomet, Inc. | 1994 | — |
| −1 | K142550 | EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments | Microport Orthopedics, Inc. | 2014 | — |
| 0 (this device) | K182125 | EVOLUTION Stemmed CS Femur | Microport Orthopedics, Inc. | 2018 | — |
| +1 | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and… | Microport Orthopedics, Inc. | 2025 | — |
| +2 | K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026 | — |
| +1 | K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | Microport Orthopedics, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K142550 | EVOLUTION MP Revision Femur, EVOLUTION Femoral AugmentsSummary page 4…Class II Subject Product Code and Panel Code: Orthopedics/87/JWH Predicate Device: EVOLUTION® MP Revision Femoral System (K142550) Reference Devices: EVOLUTION® Revision CCK System (K171389)… | 2014 |
| † | K171389 | EVOLUTION Revision CCK System | 2017 |
| † | K093552 | Evolution MP Total Knee System | 2010 |
| † | K102380 | Evolution MP Total Knee System | 2011 |
What descends from it? (3)
2 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?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 20.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243574 (Microport Orthopedics, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K142550.
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. 2018, 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?
MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
1) noninflammatory 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.
Non-porous MicroPort total knee replacement implants are for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182125: EVOLUTION Stemmed CS Femur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182125
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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