510(k) K243768

iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System by Restor3D, Inc. — Product Code MBH

K243768 is an FDA 510(k) premarket notification submitted by Restor3D, Inc. for the device "iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System". The FDA issued a decision of Substantially Equivalent on March 27, 2025. 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. Restor3D, Inc. has at least 10 other 510(k) clearances on record.