restor3d, a company specializing in 3D-printed, personalized orthopedic solutions, announced successful completion of the first clinical cases using its iTotal Identity CR 3DP porous full personalized total knee replacement (TKR) system.

According to the company, the iTotal Identity CR 3DP porous system is the first fully personalized, cementless TKR offering in the Identity platform. It received U.S. Food and Drug Administration (FDA) 510(k) clearance earlier this year.

The implant was built on restor3d’s digital-to-implant design workflow, which integrates CT-based planning, automated personalization, and advanced 3D-printed porous structures on all metallic components. This aims to deliver optimal fit, fixation, and function for each patient.

The inaugural procedure was performed by William J. Berghoff, MD, at Parkview Orthopedic Hospital in Fort Wayne, Indiana, marking a major milestone in the system’s limited market release.

“It’s remarkable to see a fully personalized, cementless knee replacement come to life in the operating room,” said Dr. 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.”

More about the iTotal Identity CR 3DP’s technology

The cementless TKR system uses restor3d’s proprietary TIDAL technology on the tibia, femur, and patella implants. The porous architecture was engineered for better osseointegration strength, fatigue resistance, and load distribution.

The tibial baseplate, designed to individual patient anatomy, provides optimal bone coverage without sacrificing component rotation, critical for successful cementless fixation. The femoral component preserves each patient’s native joint mechanics through restoration of their individual J-curves.

Delivered in a sterile, single-use kit, the system also incorporates a pre-navigated surgical workflow.

“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.”

The company will continue collaborating with select surgeon partners throughout the system’s limited market release, collecting clinical insights as it moves toward a full commercial launch.