510(k) · Cleared
ClearedEVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base
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 Nov 16, 2015 as substantially equivalent to K143366 (Microport Orthopedics, Inc., 2015) after a 95-day review. Its family tree reaches back 2 generations to 2005. 8 later devices descend from it.
- Decided
- Nov 16, 2015
- Review
- 95 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K043083 (2005). 8 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK043083 Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular…Wrightmedicaltechnologyinc · 2005
- 1 generation backK143366 ADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc. · 2015
- This deviceK152298 EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE…Microport Orthopedics, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK162026 EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block…Microport Orthopedics, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK171389 EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253728 EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
- Descendant · 3 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- K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION…Microport Orthopedics, Inc. · 2017 · cites it directly7descendants
- K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017 · 2 generations on3descendants
- K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025 · cites it directly1descendant
- K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026 · cites it directly0descendants
- K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K043083 | Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel | Wrightmedicaltechnologyinc | 2005 | — |
| −1 | K143366 | ADVANCE Porous Coated Spiked Tibial Base | Microport Orthopedics, Inc. | 2015 | — |
| 0 (this device) | 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 | — |
| +2 | K171389 | EVOLUTION Revision CCK System | Microport Orthopedics, Inc. | 2017 | — |
| +1 | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and… | Microport Orthopedics, Inc. | 2025 | — |
| +1 | K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026 | — |
| +3 | 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 |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 MBH? 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? (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 |
|---|---|---|---|
| * | K143366 | ADVANCE Porous Coated Spiked Tibial BaseSummary page 5…Class II Subject Product Code and Panel Code: Orthopedics/87/MBH Predicate Device: ADVANCE® Porous Coated Spiked Tibial Base (K143366) Reference Devices: ADVANCE® HA Coated Components (K043083) ADV… | 2015 |
| † | K043083 | Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel | 2005 |
| † | K063128 | Advance Spiked Porous Tibial Base | 2007 |
| † | 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)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION… | 2017 | 7 |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | 2025 | 1 |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | 2026 | 0 |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | 2022 | 0 |
| K180317 | EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION®… | 2018 | 0 |
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 10 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162026 (Microport Orthopedics, Inc., 2017) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K143366.
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. 2015, 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® BIOFOAM® Tibial 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 disease, including rheumatoid arthritis; 3. Correction of functional deformity 4. Revision procedures where other treatments or devices have failed; and treatment of…
Read the full statement (163 words)
The EVOLUTION® BIOFOAM® Tibial 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 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® BIOFOAM® Tibial System is for use without bone cement.
The ADVANCE® BIOFOAM® Tibial 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 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 ADVANCE® BIOFOAM® Tibial System is for use without bone cement and is intended for use with
EVOLUTION® and ADVANCE® modular keels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152298 · printed Nov 4, 2026
Cite this page
510(k) Report. “K152298: EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K152298
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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