510(k) K233980

ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System by Depuy Ireland UC — Product Code KRO

K233980 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System". The FDA issued a decision of Substantially Equivalent on March 21, 2024. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Depuy Ireland UC has at least 10 other 510(k) clearances on record.