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The Tracker / August 2026 / K253728

510(k) cleared

EVOLUTION® AM BIOFOAM® Tibial System

Microport Orthopedics, Inc. · Aug 21, 2026 · K253728

FDA cleared the EVOLUTION® AM BIOFOAM® Tibial System from Microport Orthopedics, Inc. on Aug 21, 2026 under K253728, a traditional 510(k). The device falls under product code MBH, Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, regulated at 21 CFR 888.3565 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 24, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Microport Orthopedics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253728?

K253728 is the FDA 510(k) for EVOLUTION® AM BIOFOAM® Tibial System, submitted by Microport Orthopedics, Inc.. FDA's decision date was Aug 21, 2026, under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer).

Who makes the EVOLUTION® AM BIOFOAM® Tibial System?

Microport Orthopedics, Inc., based in Arlington, TN, is the applicant of record for K253728.

How long did the K253728 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Aug 21, 2026, 270 days later.

← All decisions in August 2026