EVOLUTION® AM BIOFOAM® Tibial System
FDA 510(k) K253728 · Microport Orthopedics, Inc.
510(k) numberK253728
Submission
- Device name
- EVOLUTION® AM BIOFOAM® Tibial System
- Applicant
- Microport Orthopedics, Inc.
Arlington, TN, US - Received
- November 24, 2025
- Decision date
- August 21, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3565
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | Smith & Nephew, Inc. | 09/08/2026SE |
| K251840 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | Zimmer, Inc. | 05/28/2026SE |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)MBH · Traditional | Zimmer, Inc. | 03/09/2026SE |
| K253328 | GMK 3D Metal Tibial Tray ExtensionMBH · Traditional | Medacta International S.A. | 02/26/2026SE |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 02/18/2026SE |
| K253239 | Active-V Total Knee System; World Total Knee SystemMBH · Traditional | Signature Orthopaedics Pty, Ltd. | 12/23/2025SE |
| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | Ortho Development Corp. | 12/19/2025SE |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH · Traditional | Maxx Orthopedics, Inc. | 10/31/2025SE |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/24/2025SE |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ PatellaMBH · Traditional | United Orthopedic Corporation | 07/31/2025SE |
More from United Orthopedic Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K250444 | NEXUS® Hip StemLZO · Traditional | 05/15/2025SE |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueJWH · Traditional | 02/18/2025SE |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO HipsLPH · Traditional | 04/18/2024SE |
| K240452 | Ceramic Femoral HeadLZO · Traditional | 04/12/2024SE |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral…KRO · Traditional | 04/01/2024SE |
| K233507 | EVOLUTION® Tibial ConesMBH · Traditional | 01/18/2024SE |
| K231947 | EVOLUTION® Cement KeelJWH · Traditional | 10/31/2023SE |
| K230563 | EVOLUTION® Hinge Knee SystemKRO · Traditional | 09/27/2023SE |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMBH · Special | 01/05/2022SE |
| K213816 | MPO Hip InstrumentsJDI · Special | 01/05/2022SE |
Questions and answers
When was EVOLUTION® AM BIOFOAM® Tibial System cleared by the FDA?
EVOLUTION® AM BIOFOAM® Tibial System (K253728) received a 510(k) decision of Substantially Equivalent on August 21, 2026, 270 days after the submission was received.
What is the product code of K253728?
The FDA product code is MBH – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3565.