510(k) · Cleared
ClearedEVOLUTION® AM BIOFOAM® Tibial System
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 21, 2026 as substantially equivalent to K152298 (Microport Orthopedics, Inc., 2015) and 1 other predicate after a 270-day review. Its family tree reaches back 17 generations to 1994. 1 of the 202 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 21, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K941847 (1994). 202 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet. 1 of the 202 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 13 generations between
- 3 generations backK162035 GMK SphereMedacta International S.A. · 2017
- 2 generations backK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
- 1 generation backK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
- This deviceK253728 EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
Show all 17 generations
- Root · 17 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 16 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 15 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 14 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 13 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 12 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 11 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 10 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 9 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 8 generations backK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- 7 generations backK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- 6 generations backK113571 GMK Resufacing Patella Size 4Medacta International · 2012
- 5 generations backK121416 GMK SphereMedacta International · 2012
- 4 generations backK140826 GMK Sphere ExtensionMedacta International · 2014
- 3 generations backK162035 GMK SphereMedacta International S.A. · 2017
- 2 generations backK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
- 1 generation backK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
- This deviceK253728 EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
Class I recalls in this family
- K061223 Advance Total Knee System3 generations back · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −16 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −15 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −14 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −13 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −12 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −11 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −10 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −9 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −8 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| −7 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| −6 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
| −5 | K121416 | GMK Sphere | Medacta International | 2012 | — |
| −4 | K140826 | GMK Sphere Extension | Medacta International | 2014 | — |
| −3 | K162035 | GMK Sphere | Medacta International S.A. | 2017 | — |
| −2 | K173890 | GMK Sphere - Kinematic Alignment | Medacta International S.A. | 2018 | — |
| −1 | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and… | Microport Orthopedics, Inc. | 2025 | — |
| 0 (this device) | K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 12 | 0 |
| 1995 | 13 | 0 |
| 1996 | 13 | 0 |
| 1997 | 9 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 11 | 0 |
| 2003 | 10 | 0 |
| 2004 | 7 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 1 |
| 2007 | 12 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE…Summary page 5…esis Class II Subject Product Code and Orthopedics/87/MBH Panel Code: Primary Predicate Device: EVOLUTION® BIOFOAM® Tibial System, K152298 Secondary Predicate EVOLUTION® Total Knee Systems – Kinematic Alignment Device: Instrumentation an… | 2015 |
| * | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueSummary page 5…OAM® Tibial System, K152298 Secondary Predicate EVOLUTION® Total Knee Systems – Kinematic Alignment Device: Instrumentation and Technique, K243574 Reference Devices: EVOLUTION® MP Total Knee System, K093552 EVOLUTION® MP Total Knee Syst… | 2025 |
| † | K093552 | Evolution MP Total Knee System | 2010 |
| † | K102380 | Evolution MP Total Knee System | 2011 |
| † | K973524 | Advance Modular Tibial Component | 1997 |
| † | K140735 | Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts | 2014 |
| † | K202705 | Prime and DYNASTY® Additive Manufacturing Shells | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 111 Class I recalls
What does this lineage say?
- The line of descent spans 32 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 78 of the 201 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K152298.
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. 2026, 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® AM 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…
Read the full statement (151 words)
The EVOLUTION® AM 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® AM BIOFOAM® Tibial System is for uncemented use only.
The EVOLUTION® AM BIOFOAM® Tibial System can be implanted using the Kinematic Alignment technique. When the Kinematic Alignment approach is utilized, the devices are indicated for 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
The Evolution® Kinematic Alignment technique may only be used with Evolution® Primary knee components or the Evolution® Stemmed CS Femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253728: EVOLUTION® AM BIOFOAM® Tibial System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253728
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026