510(k) K222056

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code JDI

K222056 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics for the device "Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee". The FDA issued a decision of Substantially Equivalent on January 26, 2023. 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.