Picture: restor3d
The US company restor3d has completed the first clinical procedures using its iTotal Identity CR 3DP Porous System. This is a fully personalized, cementless total knee arthroplasty (TKA) system within the Identity platform, which received 510(k) clearance from the FDA earlier this year. The first procedure was performed by William J. Berghoff at Parkview Orthopedic Hospital in Fort Wayne, Indiana, and is part of a limited market release.
Technically, the system is based on an end-to-end digital workflow: CT data is first used to generate a patient-specific 3D model of the knee joint. Building on this, the implant geometries are automatically personalized and manufactured as porous metal components using 3D printing. All metallic components – tibial baseplate, femoral component and patellar component – feature an additively produced, open porous structure designed to enable bony ingrowth. Berghoff emphasizes that the combination of patient-specific geometry and finely tuned pore architecture provides high stability and coverage in the OR and that his first patients have shown “very good progress.”
“It’s remarkable to see a fully personalized, cementless knee replacement come to life in the operating room,” said Dr. William J. Berghoff. “The combination of patient-specific design and a truly advanced porous architecture provide a level of stability, coverage, and precision that is unlike anything we’ve used before. My patients had an excellent experience, and I’m excited about what this technology means for the future of knee replacement.”
At the heart of the cementless variant is restor3d’s TIDAL technology, a specially optimized pore structure with defined stiffness and load distribution. The tibial component is designed to match the individual bone contour without compromising the free rotation of the implant, which is central to cementless fixation. The femoral implant is aligned with the patient’s individual J-curves and is thus intended to stay as close as possible to the original joint kinematics.
For the operating room, the system is supplied as a sterile single-use set with a pre-planned resection strategy. This eliminates many intraoperative adjustments that are common with conventional modular systems.
“Launching the first cementless, personalized and fully 3D printed knee system into clinical use is a transformative step for orthopedic care,” said Ken Gall, CCO of restor3d. “We are proud to partner with leading surgeons like Dr. Berghoff as we continue advancing truly individualized joint replacement options that improve patient outcomes and strengthen the standard of care.”
For additive manufacturing in orthopedics, the project marks another step toward fully digitally planned, personalized implants with complex 3D-printed porous structures.
