Restor3D, Inc. · Class II · Cleared Mar 27, 2025
| K-number | K243768 |
| Device name | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System |
| Applicant | Restor3D, Inc. |
| Product code | MBH |
| Device class | Class II |
| Decision date | Mar 27, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3565 |
The iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is a patient-specific total knee replacement implant composed of three components (femoral, tibial, and patellar) designed from patient CT scans. It is intended for patients with severe knee pain and disability from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or osteonecrosis who require treatment of all three knee compartments.
The subject device uses additively manufactured (3D-printed) components with an integrally built TIDAL porous surface lattice for cementless fixation, compared to the primary predicate which uses traditional porous coating. The femoral component is cobalt chromium molybdenum, the tibial tray is titanium, and the patellar backing is porous titanium. The functional specifications and materials of components match the secondary predicate (iTotal Identity CR KRS), but the subject device is designed for cementless rather than cemented fixation.
Not stated in this summary.
The device maintains the same functional specifications and materials as the secondary predicate (iTotal Identity CR KRS) while adopting the cementless fixation approach of the primary predicate (Identity™ Imprint™ Porous CR KRS). The additively manufactured TIDAL porous lattice design for cementless fixation is the same technology used in the reference devices (Kinos Total Ankle System). Non-clinical testing including fatigue, wear, biocompatibility, and porous coating testing per FDA guidance demonstrates safety and effectiveness equivalent to the predicates, with no design differences raising different questions of safety or effectiveness.
View the full FDA submission: accessdata.fda.gov