510(k) K213701

Exeter® X3® RimFit® Cup by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code JDI

K213701 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics for the device "Exeter® X3® RimFit® Cup". The FDA issued a decision of Substantially Equivalent on February 1, 2022. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Howmedica Osteonics Corp., Dba Stryker Orthopaedics has at least 10 other 510(k) clearances on record.