510(k) K233507

EVOLUTION® Tibial Cones by Microport Orthopedics, Inc. — Product Code MBH

K233507 is an FDA 510(k) premarket notification submitted by Microport Orthopedics, Inc. for the device "EVOLUTION® Tibial Cones". The FDA issued a decision of Substantially Equivalent on January 18, 2024. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Microport Orthopedics, Inc. has at least 10 other 510(k) clearances on record.