510(k) K240639

PINNACLETM Constrained Acetabular Liners by Depuy Ireland UC — Product Code KWZ

K240639 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "PINNACLETM Constrained Acetabular Liners". The FDA issued a decision of Substantially Equivalent on April 4, 2024. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. Depuy Ireland UC has at least 10 other 510(k) clearances on record.