510(k) K190991

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) — Product Code MBH

K190991 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) for the device "Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment". The FDA issued a decision of Substantially Equivalent on Aug 15, 2019. 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. (Aka Stryker Orthopaedics) has 1 other 510(k) clearance on record.