restor3d Announces First Clinical Cases of the iTotal Identity™ CR 3DP Porous Fully Personalized Total Knee Replacement System

DURHAM, N.C.--(BUSINESS WIRE)--restor3d, a leader in 3D-printed, personalized orthopedic solutions, today announced the successful completion of the first clinical cases using the iTotal Identity™ CR 3DP Porous Fully Personalized Total Knee Replacement System. 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 and the next evolution of personalized knee arthroplasty.

The iTotal Identity CR 3DP Porous System represents the first fully personalized, cementless total knee replacement offering within the Identity platform, following FDA 510(k) clearance earlier this year. Built on restor3d’s proven digital-to-implant design workflow, the system integrates CT-based planning, automated personalization, and advanced 3D-printed porous structures on all metallic components to deliver optimal fit, fixation, and function for every patient.

“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.”

The cementless system leverages restor3d’s proprietary TIDAL Technology™ on the tibia, femur, and patella implants. This next-generation porous architecture is engineered to achieve optimized osseointegration strength, enhanced fatigue resistance, and efficient 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, reducing intraoperative variability and streamlining operating room efficiency. By eliminating intraoperative adjustments associated with traditional implant sets, surgeons can rely on a consistent and reproducible implantation experience tailored to each patient's anatomy.

“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.”

restor3d will continue collaborating with select surgeon partners throughout the system’s limited market release, gathering clinical insights as it moves toward a full commercial launch.

About restor3d, Inc.

restor3d is a world leader in 3D printed patient specific musculoskeletal implants and driven by the belief that every patient deserves personalized care. The company holds proprietary expertise and intellectual property in 3D printing of osseointegrative materials, AI-based planning and design automation tools, and digital health solutions to provide seamless data-backed care to optimize individual patient outcomes. Alongside its customers, restor3d is reimagining the musculoskeletal reconstruction landscape. More information is available at www.restor3d.com.

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