510(k) K172634

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics — Product Code MBH

K172634 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics for the device "Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components". The FDA issued a decision of Substantially Equivalent on November 16, 2017. 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. A.K.A. Stryker Orthopaedics has at least 8 other 510(k) clearances on record.