510(k) K261275

Unity Total Knee System, Unity Knee Cementless CR Femur by Corin, Ltd. — Product Code MBH

K261275 is an FDA 510(k) premarket notification submitted by Corin, Ltd. for the device "Unity Total Knee System, Unity Knee Cementless CR Femur". The FDA issued a decision of Substantially Equivalent on September 17, 2026. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Corin, Ltd. has at least 3 other 510(k) clearances on record.