510(k) · Cleared
Recalled · Class II · 2024Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Aug 29, 2014 as substantially equivalent to K093552 (Wrightmedicaltechnologyinc, 2010) and 5 other predicates after a 158-day review. Its family tree reaches back 4 generations to 2004. 1 of the 17 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled once.
- Decided
- Aug 29, 2014
- Review
- 158 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 4 generations to K033890 (2004). 11 ancestors in all, the oldest K894334 (1989). 5 later devices descend from it, 4 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK033890 Advance Double High InsertWrightmedicaltechnologyinc · 2004
- 3 generations backK102380 Evolution MP Total Knee SystemWrightmedicaltechnologyinc · 2011 · Recalled
- 2 generations backK113325 Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc · 2011
- 1 generation backK131679 Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc · 2013
- This deviceK140735 Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc. · 2014
- 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 ownK240043 EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW…Microport Orthopedics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK213817 MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK152631 MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc. · 2016
Class I recalls in this family
- K061223 Advance Total Knee Systemdirect predicate · 2006
Most influential descendants
Showing 5 of 5 · 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
- K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc. · 2024 · cites it directly0descendants
- K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc. · 2022 · cites it directly0descendants
- K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K033890 | Advance Double High Insert | Wrightmedicaltechnologyinc | 2004 | — |
| −3 | K102380 | Evolution MP Total Knee System | Wrightmedicaltechnologyinc | 2011 | 4 |
| −2 | K113325 | Evolution MP Adaptive CS Insert | Wrightmedicaltechnologyinc | 2011 | — |
| −1 | K131679 | Evolution MP Adaptive PS Tibial Insert | Wrightmedicaltechnologyinc | 2013 | — |
| 0 (this device) | K140735 | Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts | Microport Orthopedics, Inc. | 2014 | — |
| +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 | K240043 | EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal… | Microport Orthopedics, Inc. | 2024 | — |
| +1 | K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | Microport Orthopedics, Inc. | 2022 | — |
| +1 | K152631 | MPO Total Knee Systems MR Labeling | Microport Orthopedics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 2 | 0 |
| 2006 | 1 | 1 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 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.
1 device in this family has a Class I recall. 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 20.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K093552 | Evolution MP Total Knee SystemSummary page 4…Orthopedics/87/MBH Orthopedics/87/MBH, JWH Predicate Devices: EVOLUTION® MP CS/CR Non-Porous Femur (K093552, K102380) ADVANCE® Porous Femur (K061223) EV… | 2010 |
| * | K102380 | Evolution MP Total Knee SystemSummary page 4…opedics/87/MBH Orthopedics/87/MBH, JWH Predicate Devices: EVOLUTION® MP CS/CR Non-Porous Femur (K093552, K102380) ADVANCE® Porous Femur (K061223) EVOLUTION®… | 2011 |
| * | K061223 | Advance Total Knee SystemSummary page 4…H, JWH Predicate Devices: EVOLUTION® MP CS/CR Non-Porous Femur (K093552, K102380) ADVANCE® Porous Femur (K061223) EVOLUTION® Adaptive CS Insert (K113325) EVO… | 2006 |
| * | K113325 | Evolution MP Adaptive CS InsertSummary page 4…ur (K093552, K102380) ADVANCE® Porous Femur (K061223) EVOLUTION® Adaptive CS Insert (K113325) EVOLUTION® Adaptive PS Insert (K131679) ADVA… | 2011 |
| * | K131679 | Evolution MP Adaptive PS Tibial InsertSummary page 4…mur (K061223) EVOLUTION® Adaptive CS Insert (K113325) EVOLUTION® Adaptive PS Insert (K131679) ADVANCE® Spiked Porous Tibial Base (K063128)… | 2013 |
| * | K063128 | Advance Spiked Porous Tibial BaseSummary page 4…(K113325) EVOLUTION® Adaptive PS Insert (K131679) ADVANCE® Spiked Porous Tibial Base (K063128) 005-1 === Page 5… | 2007 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | 2025 | 1 |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral… | 2024 | 0 |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | 2022 | 0 |
| K152631 | MPO Total Knee Systems MR Labeling | 2016 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2024 | Class II | Z-0699-2025 | Labeling Change Control | Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061223Advance Total Knee SystemWrightmedicaltechnologyinc · 2006 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 111 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243574 (Microport Orthopedics, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 14 other devices also cite its predicate K093552.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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 · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
The EVOLUTION® MP CS/CR Porous Femur 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® MP CS/CR Porous Femur is for uncemented 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/K140735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140735: Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140735
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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