510(k) K200782

Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite by Howmedica Osteonics Corp. — Product Code MBH

K200782 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite". The FDA issued a decision of Substantially Equivalent on May 13, 2020. 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. has at least 10 other 510(k) clearances on record.