510(k) clearance
EVOLUTION® AM BIOFOAM® Tibial System
- 510(k) number
- K253728
- Applicant
- Microport Orthopedics, Inc.
- Decision date
- Aug 21, 2026
- Date received
- Nov 24, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MBH
- Device type
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class II
- Regulation
- 21 CFR 888.3565
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Arlington, TN, US