510(k) K260831

Z1 Hip System by Zimmer, Inc. — Product Code LZO

K260831 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Z1 Hip System". The FDA issued a decision of Substantially Equivalent on June 16, 2026. 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. Zimmer, Inc. has at least 10 other 510(k) clearances on record.