U.S.-based medical technology company restor3d has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its iTotal Identity CR 3DP Porous Total Knee Replacement System. With this approval, restor3d expands its portfolio of personalized knee replacement solutions by adding a cementless system based on technology acquired from Conformis in 2023. A limited commercial launch is planned for the third quarter of 2025.
The system combines patient-specific design with a 3D-printed porous implant structure. Unlike traditional cemented prostheses, the cementless version relies on biological integration through an optimized surface texture, aiming for long-term stable fixation without the use of bone cement. Both the femoral and tibial components are tailored to the patient’s unique anatomy to support natural joint mechanics. Preoperative planning is performed digitally, and the surgical system includes customized single-use instruments and pre-sterilized implants to optimize operating room workflows.
“For the first time, we have a truly patient-specific, cementless knee replacement option, and that’s incredibly exciting,” said Brian Palumbo, MD at Florida Orthopaedic Institute, Florida. “The cementless tibial baseplate is designed for optimal stability and fixation, providing maximum coverage without overhang or compromise in rotational alignment. Its strategically placed peripheral pegs enhance stability while avoiding impingement with the tibial cortex, a key factor for long-term implant success. Combined with a femoral component that maintains the patient’s native joint mechanics, this system offers a more natural feel and function for patients undergoing knee replacement.”
A core element of the system is restor3d’s TIDAL technology, which features a lattice design optimized for osseointegration, improved fatigue strength, and better load distribution compared to conventional truss structures. All three implant components—femur, tibia, and patella—utilize this 3D-printed architecture to promote bone ingrowth.
During the product’s rollout, restor3d will collaborate closely with select orthopedic centers to gather clinical feedback and further refine the system. The company’s approach centers on the combination of additive manufacturing, digital planning, and personalized surgical solutions.
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