DeviceClearance

EVOLUTION® AM BIOFOAM® Tibial System— 510(k) K253728

Substantially Equivalent

Microport Orthopedics, Inc.

FDA 510(k) clearance K253728 for EVOLUTION® AM BIOFOAM® Tibial System, Substantially Equivalent on 2026-08-21. Applicant: Microport Orthopedics, Inc.. Device class: 2.

Summary

MicroPort Orthopedics filed the EVOLUTION AM BIOFOAM Tibial System under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer). The record gives no model numbers.

Class II, 21 CFR 888.3565. Orthopedic is both the classification panel and the review panel. The submission was a Traditional 510(k).

MicroPort filed from Arlington, Tennessee. Review took 270 calendar days (November 24, 2025 to August 21, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant
Microport Orthopedics, Inc.
Product code
Product code MBH
Device class
Class 2
Regulation
21 CFR 888.3565
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arlington, TN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MBH

product code MBH
Injury
6,545
Malfunction
2,023
Total
8,568

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.