510(k) K043061

THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX by Zimmer Trabecular — Product Code KWS

K043061 is an FDA 510(k) premarket notification submitted by Zimmer Trabecular for the device "THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX". The FDA issued a decision of Substantially Equivalent on November 23, 2004. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Zimmer Trabecular has at least 9 other 510(k) clearances on record.