510(k) K072575

TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE by Stryker Orthopaedics — Product Code MBH

K072575 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE". The FDA issued a decision of Substantially Equivalent on January 7, 2008. 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. Stryker Orthopaedics has at least 10 other 510(k) clearances on record.