510(k) K223069

Modular Rotating Hinge Knee Systems and Compatible Components by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code KRO

K223069 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics for the device "Modular Rotating Hinge Knee Systems and Compatible Components". The FDA issued a decision of Substantially Equivalent on April 21, 2023. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Howmedica Osteonics Corp., Dba Stryker Orthopaedics has at least 10 other 510(k) clearances on record.