510(k) K230416

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® by Stryker — Product Code KRO

K230416 is an FDA 510(k) premarket notification submitted by Stryker for the device "Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®". The FDA issued a decision of Substantially Equivalent on May 19, 2023. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Stryker has at least 10 other 510(k) clearances on record.