510(k) K132624

TRIATHLON TRITANIUM METAL-BACKED PATELLA by Stryker Orthopaedics — Product Code MBH

K132624 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "TRIATHLON TRITANIUM METAL-BACKED PATELLA". The FDA issued a decision of Substantially Equivalent on November 26, 2013. 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.