510(k) K261898

Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System by Howmedica Osteonics Corp. dba Stryker Orthopaedics — Product Code KRO

K261898 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. dba Stryker Orthopaedics for the device "Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System". The FDA issued a decision of Substantially Equivalent on August 6, 2026. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510.