510(k) K203099

Triathlon PKR System by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics — Product Code HSX

K203099 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics for the device "Triathlon PKR System". The FDA issued a decision of Substantially Equivalent on October 27, 2020. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics has at least 8 other 510(k) clearances on record.