510(k) K251665

Triathlon® Hinge Knee System by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code KRO

K251665 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics for the device "Triathlon® Hinge Knee System". The FDA issued a decision of Substantially Equivalent on July 25, 2025. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Howmedica Osteonics Corp., Dba Stryker Orthopaedics has at least 10 other 510(k) clearances on record.