510(k) K253637

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code MBH

K253637 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics for the device "Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert". The FDA issued a decision of Substantially Equivalent on February 18, 2026. 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. Howmedica Osteonics Corp., Dba Stryker Orthopaedics has at least 10 other 510(k) clearances on record.