510(k) K243571

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners by Zimmer Biomet — Product Code JDI

K243571 is an FDA 510(k) premarket notification submitted by Zimmer Biomet for the device "Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners". The FDA issued a decision of Substantially Equivalent on July 31, 2025. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Zimmer Biomet has at least 4 other 510(k) clearances on record.