510(k) K232426

Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts by Conformis, Inc. — Product Code MBH

K232426 is an FDA 510(k) premarket notification submitted by Conformis, Inc. for the device "Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts". The FDA issued a decision of Substantially Equivalent on September 8, 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.