510(k) K250571

CATALYSTEM Femoral Stems by Smith & Nephew, Inc. — Product Code LZO

K250571 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "CATALYSTEM Femoral Stems". The FDA issued a decision of Substantially Equivalent on March 28, 2025. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.