K253728
- 510(k) number
- K253728
- Device name
- EVOLUTION® AM BIOFOAM® Tibial System
- Applicant
- Microport Orthopedics, Inc. TN · US
- Product code
- MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constra
- Decision date
- 2026-08-21
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253728.pdf
Official FDA record: K253728
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.