510(k) K112438

TITAN MODULAR TOTAL SHOULDER SYSTEM by Ascension Orthopedic — Product Code KWS

K112438 is an FDA 510(k) premarket notification submitted by Ascension Orthopedic for the device "TITAN MODULAR TOTAL SHOULDER SYSTEM". The FDA issued a decision of Substantially Equivalent on April 11, 2012. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Ascension Orthopedic has at least 6 other 510(k) clearances on record.