510(k) K180612

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics — Product Code HSX

K180612 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics for the device "Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts". The FDA issued a decision of Substantially Equivalent on Jun 7, 2018. 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.