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FDA 510(k)

EVOLUTION® AM BIOFOAM® Tibial System

K-Number: K253728 · 2026-08-21

ApplicantMicroport Orthopedics, Inc.
Decision Date2026-08-21
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOLUTION® AM BIOFOAM® Tibial System is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2026-08-21 under 510(k) number K253728. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOLUTION® AM BIOFOAM® Tibial System?

EVOLUTION® AM BIOFOAM® Tibial System is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K253728.

When did EVOLUTION® AM BIOFOAM® Tibial System receive FDA 510(k) clearance?

EVOLUTION® AM BIOFOAM® Tibial System received FDA 510(k) clearance on 2026-08-21, under 510(k) number K253728.

Who is the listed applicant for EVOLUTION® AM BIOFOAM® Tibial System?

The FDA 510(k) record lists Microport Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVOLUTION® AM BIOFOAM® Tibial System?

The FDA product code for EVOLUTION® AM BIOFOAM® Tibial System is MBH.

Other records listing Microport Orthopedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250444NEXUS® Hip StemK243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueK240046Ethylene Oxide Sterilization Supplier Change for MPO HipsK240452Ceramic Femoral HeadK240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseK233507EVOLUTION® Tibial Cones

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Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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