510(k) K253161

Balanced Knee System TriMax Porous Femoral Components by Ortho Development Corp. — Product Code MBH

K253161 is an FDA 510(k) premarket notification submitted by Ortho Development Corp. for the device "Balanced Knee System TriMax Porous Femoral Components". The FDA issued a decision of Substantially Equivalent on December 19, 2025. 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. Ortho Development Corp. has at least 10 other 510(k) clearances on record.