510(k) K924115

ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS by Johnson & Johnson Orthopaedics, Inc. — Product Code JDI

K924115 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Orthopaedics, Inc. for the device "ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS". The FDA issued a decision of Substantially Equivalent on November 24, 1992. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Johnson & Johnson Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.