510(k) K123166

TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P by Howmedica Osteonics Corp. — Product Code JWH

K123166 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P". The FDA issued a decision of Substantially Equivalent on February 14, 2013. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.