510(k) K223316

Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System by Conformis, Inc. — Product Code MBH

K223316 is an FDA 510(k) premarket notification submitted by Conformis, Inc. for the device "Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System". The FDA issued a decision of Substantially Equivalent on July 21, 2023. 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. Conformis, Inc. has at least 10 other 510(k) clearances on record.